Annals of Diagnostic Pathology 74 (2025) 152411

Contents lists available at ScienceDirect

Annals of Diagnostic Pathology

journal homepage: www.elsevier.com/locate/anndiagpath

Evaluation of the recently established Dutch nationwide Archipelago of

Ovarian Cancer Research biobank
Hein S. Zelisse a,* , Mignon D.J.M. van Gent b , Constantijne H. Mom b, Sander de Ridder c ,
Malou L.H. Snijders d , Marlou Heeling a , Matthijs Stoter c , Annegien Broeks e, Hugo M. Horlings f,
Christianne A.R. Lok g , Steven L. Bosch h , Jurgen M. Piek i , Joost Bart j, Anna K.L. Reyners k,
G. Bea A. Wisman l, Refika Yigit l, Ingrid A. Boere m , Margriet Collée n , Floris H. Groenendijk o ,
Maurice P.H.M. Jansen m, Eva-Maria Roes p, Ward Hofhuis q, Klaas J. Hoogduin r,
Luthy S.M. Alcalá s , Huberdina P.M. Smedts t , Alexander C.F. Makkus u,
Gatske M. Nieuwenhuyzen-de Boer p,v , Nicole van Es w , Peggy M.L.H. Vencken x ,
Anne M. van Altena y, Michiel Simons z, Hans Marten Hazelbag aa , Marjolein J. Kagie ab,
Riena Aliredjo ac , Tijmen J.J. Bonestroo ad, Tjalling Bosse ae , Cor D. de Kroon af ,
Mariël Brinkhuis ag, Marc-Jan Janssen ah , Nils C. Koster ai,
Arnold-Jan Kruse aj, Cornelis G. Gerestein ak, Trudy G.N. Jonges al,
Ronald P. Zweemer ak, Loes F.S. Kooreman am, Sandrina Lambrechts an ,
Inge M.W. Ebisch ao , Ineke M. de Kievit van der Heijden ap , Quirinus J. Voorham aq,
Maaike A. van der Aa ar, Jeroen A.M. Belien as , Marc J. van de Vijver d,1 , Frederike Dijk d,*,1,
Archipelago of Ovarian Cancer Research Consortium
a
Department of Pathology, Cancer Center Amsterdam, Amsterdam Reproduction & Development research institute, Amsterdam UMC, University of Amsterdam,
Amsterdam, the Netherlands
b
Department of Gynaecologic Oncology, Centre for Gynaecologic Oncology Amsterdam, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam,
Amsterdam, the Netherlands
c
Department of Pathology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
d
Department of Pathology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
e
Department of CFMPB (Core Facility - Molecular Pathology and Biobanking), The Netherlands Cancer Institute, Amsterdam, the Netherlands
f
Department of Pathology, The Netherlands Cancer Institute, Amsterdam, the Netherlands
g
Department of Gynaecological Oncology, Centre for Gynaecologic Oncology Amsterdam, Antoni van Leeuwenhoek – The Netherlands Cancer Institute, Amsterdam, the
Netherlands
h
Department of Pathology, Eurofins-PAMM, Eindhoven, the Netherlands
i
Department of Obstetrics and Gynaecology, Catharina Hospital, Catharina Cancer Institute, Eindhoven, the Netherlands
j
Department of Pathology and Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands
k
Department of Medical Oncology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands
l
Department of Gynaecologic Oncology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands
m
Department of Medical Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands
n
Department of Clinical Genetics, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands
o
Department of Pathology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands
p
Department of Gynecologic Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands
q
Department of Gynaecological Oncology, Franciscus Hospital, Rotterdam, the Netherlands
r
Department of Pathology, Pathan BV, Rotterdam, the Netherlands
s
Department of Pathology, Amphia Hospital Breda, Breda, the Netherlands
t
Department of Obstetrics and Gynecology, Amphia Hospital, Breda, the Netherlands
u
Department of Pathology, PAL Laboratory for Pathology Dordrecht, Dordrecht, the Netherlands
v
Department of Obstetrics and Gynaecology, Albert Schweitzer Hospital, Dordrecht, the Netherlands
w
Department of Pathology, Bravis Hospital, Bergen op Zoom, the Netherlands
x
Department of Gynecology and Obstetrics, Bravis Hospital, Bergen op Zoom, the Netherlands
y
Department of Obstetrics & Gynecology, Radboud University Medical Center, Nijmegen, the Netherlands

* Corresponding authors at: Pathology, Amsterdam UMC, Meibergdreef 9, Amsterdam, Noord-Holland 1105AZ, the Netherlands.
E-mail addresses: h.s.zelisse@amsterdamumc.nl (H.S. Zelisse), f.dijk@amsterdamumc.nl (F. Dijk).

https://doi.org/10.1016/j.anndiagpath.2024.152411

Available online 19 November 2024

1092-9134/© 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
H.S. Zelisse et al. Annals of Diagnostic Pathology 74 (2025) 152411

z
Department of Pathology, Radboud University Medical Center, Nijmegen, the Netherlands
aa
Department of Pathology, Haaglanden Medical Center, The Hague, the Netherlands
ab
Department of Gynaecology, Haaglanden Medical Center, The Hague, the Netherlands
ac
Department of Pathology, Rijnstate Hospital, Arnhem, the Netherlands
ad
Department of Gynaecology and Obstetrics, Rijnstate Hospital, Arnhem, the Netherlands
ae
Department of Pathology, Leiden University Medical Center, Leiden, the Netherlands
af
Department of Obstetrics and Gynaecology, Leiden University Medical Center, Leiden, the Netherlands
ag
Department of Pathology, Laboratory of Pathology East Netherlands – LabPON, Hengelo, the Netherlands
ah
Department of Gynecological Oncology, Medical Spectrum Twente, Enschede, the Netherlands
ai
Department of Pathology, Isala Clinics, Zwolle, the Netherlands
aj
Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, the Netherlands
ak
Department of Gynaecological Oncology, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, the Netherlands
al
Department of Pathology, University Medical Center Utrecht, Utrecht, the Netherlands
am
Department of Pathology, GROW School for Oncology and Reproduction, Maastricht University Medical Center+, Maastricht, the Netherlands.
an
Department of Obstetrics and Gynaecology, Maastricht University Medical Center+, Maastricht, the Netherlands
ao
Department of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands
ap
Department of Pathology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands
aq
Palga Foundation, Houten, the Netherlands
ar
Department of Research and Development, IKNL – Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands
as
Department of Pathology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands

A R T I C L E I N F O A B S T R A C T

Keywords: Fundamental and translational research in ovarian cancer aims to enhance understanding of disease mechanisms
Ovarian cancer and improve treatment and survival outcomes. To support this, we established the Dutch multicenter, inter-
Biobank disciplinary Archipelago of Ovarian Cancer Research (AOCR) infrastructure, which includes a nationwide bio-
Fundamental research
bank. In this study, we share our experiences in establishing the infrastructure, offer guidance for similar
Translational research
initiatives, and evaluate the AOCR patient cohort. Key challenges included obtaining Data Protection Impact
Research infrastructure
Assessment (DPIA) clearance, drafting the consortium agreement, and securing ethical approval from all hos-
pitals. Over three years, 1093 patients were enrolled across 17 hospitals, resulting in the collection of 1339 tissue
samples and 2280 blood samples. Of the 523 patients with currently available clinical and pathological data, 74
% (n = 387) had primary ovarian cancer. Among these patients, 73.4 % was diagnosed with high-grade serous
ovarian carcinoma, and 80.9 % presented with advanced-stage disease. Surgery was performed on 93 % of
patients with primary ovarian cancer, and chemotherapy was administered to 90.4 % of these patients. In
conclusion, the AOCR biobank has established a robust foundation for future fundamental and translational
ovarian cancer research. This manuscript provides valuable insights and guidance for developing future research
infrastructures and biobanks, and contains detailed information about the AOCR patient cohort to date.

1. Introduction eight regional gynecological oncology networks. Each network consists

of a coordinating oncological center and participating hospitals. The
Ovarian cancer is the deadliest gynecologic malignancy in developed national Dutch Gynecological Oncology Group coordinates the clinical
countries, with a five-year overall survival rate below 50 % [1-3]. Pa- research across these networks. However, a centralized approach for
tients with early-stage disease, defined as International Federation of fundamental and translational research was missing. To resolve this, the
Gynecology and Obstetrics (FIGO) stage I and II, have the most favorable Archipelago of Ovarian Cancer Research (AOCR) was established in
survival outcomes. Following staging surgery and, if indicated, 2019. The AOCR encompasses all 18 Dutch hospitals where ovarian
platinum-based chemotherapy, their five-year overall survival rate is cancer surgery is performed, with the exception of one due to resource
approximately 80 %. Conversely, this rate is <30 % in patients with limitations at the department of Pathology. As a Dutch multicenter,
advanced-stage disease (FIGO stage III and IV), who are treated with interdisciplinary research infrastructure, the AOCR aims to advance
debulking surgery and (neo)adjuvant platinum-based chemotherapy [1- fundamental and translational ovarian cancer research, thereby ulti-
4]. Recent advancements in treatment strategies have led to improve- mately improving ovarian cancer treatment and survival outcomes
ments in survival outcomes of advanced-stage ovarian cancer patients. [8,9].
For example, the addition of hyperthermic intraperitoneal chemo- Given the increasingly recognized variation in tumorigenesis pat-
therapy to interval debulking surgery in FIGO stage III patients has terns, molecular profiles, and treatment outcomes within ovarian can-
improved the ten-year overall survival rate from 12.2 % to 18 %, cer, studies on specific (molecular) subgroups are becoming increasingly
although not routinely performed in all countries [5]. Moreover, the important [10-12]. To perform these types of fundamental and trans-
implementation of maintenance therapy with poly (ADP-ribose) poly- lational studies, the availability of a sufficient number of high-quality
merase (PARP) inhibitors in BRCA-mutated patients with stage III or IV biomaterials is essential [13]. This is only feasible through multicenter
high-grade serous or endometrioid ovarian cancer improved the five- collaboration and requires uniformity in the collection, processing, and
year overall survival rate from 63.4 % to 73.1 % [6]. Nonetheless, storage of the various types of biomaterials from all patients, at different
apart from these subgroups, the long-term survival has hardly improved, stages of their treatment, across all participating hospitals. Therefore, a
underscoring the urgent need for ongoing ovarian cancer research to biobank has been established within the AOCR infrastructure. This
achieve further improvement in survival outcomes [3]. biobank contains blood and tissue samples from patients with (sus-
In the Netherlands, approximately 1400 patients are diagnosed with pected) ovarian cancer who have given informed consent, allowing for
ovarian cancer annually [7]. These patients are treated within one of the the storage and use of their biomaterials in future studies [8]. The study
protocol for this biobank, detailing the procedures for patient recruit-
ment, informed consent, collection and storage of biomaterials, acqui-
sition of clinical and pathological data, and the issuance of biomaterials
1
These authors share senior authorship.

2
H.S. Zelisse et al. Annals of Diagnostic Pathology 74 (2025) 152411

and data, has been described in our previous article [8]. 2.3. Data collection
Currently, the AOCR biobank has been operational for three years.
Here, we provide an overview of the patients included in this period and Clinical data from ovarian cancer patients included in the AOCR
the samples stored. Additionally, we highlight valuable lessons learned between 2020 and 2022 were acquired from the NCR, excluding those
throughout this period. We believe these insights will be instrumental who were enrolled at the time of suspecting or diagnosing a recurrence.
for the establishment and coordination of future research infrastructures Data for patients included in 2023 were not acquired due to the data still
and biobanks. being collected by the NCR at the time of the study. The pathology re-
ports of the AOCR patients were obtained via Palga.
2. Materials and methods
2.4. Ethical considerations
2.1. Ethical review procedure
The executive board of the Medical Research Ethics Committee of the
To ensure compliance with legislation and regulations, and to safe-
Amsterdam UMC, location Amsterdam Medical Center (University of
guard the safety and privacy of biobank participants, the establishment
Amsterdam), determined that the AOCR biobank is not subject to the
of a biobank in the Netherlands is reviewed by the Medical Research
Dutch Directive on Medical Research Involving Human Subjects (refer-
Ethics Committee, Biobank Review Committee, or Institutional Review
ence: W20_083) [8,22]. The Biobank Review Committee of the
Board of each participating hospital [14,15]. This review includes the
Amsterdam UMC, location Amsterdam Medical Center (University of
study protocol and the informed consent form, as well as the Data Pro-
Amsterdam), granted approval for the establishment of the AOCR bio-
tection Impact Assessment (DPIA) and the consortium agreement. A
bank (reference: 2019_272). Subsequently, the Medical Research Ethics
DPIA is a systematic approach designed to identify and mitigate privacy
Committee, Biobank Review Committee, or Institutional Review Board
risks in data processing activities. This process includes outlining the
of each participating hospital approved the local establishment of the
types of data being processed, evaluating their necessity relative to the
biobank [8]. The AOCR biobank protocols are in accordance with the
intended objectives, identifying potential privacy risks, and determining
Declaration of Helsinki [23]. Additionally, the issuance of data for this
appropriate measures to minimize or prevent these risks. It also involves
study was approved by the scientific and privacy boards of the NCR and
making informed decisions on the implementation of measures to ensure
Palga. All data retrieval and handling procedures adhered to the General
compliance with the General Data Protection Regulation [16,17]. A
Data Protection Regulation Act (GDPR) [17].
consortium agreement is a formal document that outlines the terms and
conditions of collaboration between multiple institutions [18].
3. Results

2.2. The Archipelago of Ovarian cancer Research biobank 3.1. Lessons learned during the implementation phase

The recruitment and informed consent procedures for the biobank The initial medical ethical review process for the AOCR biobank was
have been described previously [8,9]. In short, patients who are either conducted at the coordinating center (Amsterdam UMC), followed by
suspected of, or diagnosed with ovarian cancer are invited to participate. review in all participating hospitals. In addition to standard consider-
Upon providing written informed consent, the participants are regis- ations for biobank implementation, such as determining the optimal
tered in Ldot, a web-based tool for storing personal data [19]. Informed timing for informed consent, deciding which biomaterials to collect at
consent allows for the collection and storage of various biomaterials for various treatment stages, and selecting the standard operating proced-
future (genetic) research. The specific types of biomaterials collected, ures to adhere to, we encountered three significant challenges that
and the timing of their collection, depend on the treatment of the patient required more time and effort than initially anticipated during the
and on their availability (Table 1). Furthermore, participants consent to establishment of the biobank. These were (i) obtaining clearance for the
the linkage of their data with other Dutch registries, including the DPIA (one year), (ii) drafting a comprehensive consortium agreement
Netherlands Cancer Registry (NCR) and the Dutch nationwide pathology (one year), and (iii) obtaining approval from the review committees of
databank (Palga). The NCR collects clinical data of all cancer patients in all participating hospitals (two years). In Table 2, we outline the tasks
the Netherlands, while Palga archives all pathology reports [20,21]. involved and the personnel required, and provide practical tips for
Additionally, patients can allow for, or refuse to, the use of their data addressing these challenges, based on our experiences.
and biomaterials by commercial entities, and by institutes in countries The drafting of the DPIA and its subsequent review by the Data
that do not conform to Dutch privacy standards. Lastly, patients can also Protection Officer and the IT Security Officer was a time-consuming
for, or refuse to, being approached for follow-up research [8,9]. process, due to the software used for storing personal data not having

Table 1
Overview of the options for biomaterial collection, stratified by surgical treatment received. IDB, interval debulking; PDB, primary debulking.
Staging surgery Primary debulking surgery Interval debulking surgery

Tissue Tumor tissue, treatment-naïve (biopsy)a ✓ ✓ ✓

Ascites, treatment-naïve (paracentesis)b ✓ ✓ ✓
Tumor tissue (surgery)a ✓ ✓ ✓
Digital slide ✓ ✓ ✓
Blood Baselinec ✓ ✓ ✓
Pre-IDBd ✓
Post-PDB1e ✓
Post-PDB2f ✓
a
Stored as fresh-frozen and formalin-fixed paraffin-embedded tissue.
b
Stored as a cellblock prepared using the agar cellblock method or Cellient™ automated cell block system.
c
Includes serum, plasma, whole blood and cell-free plasma, collected before the start of treatment.
d
Includes whole blood and cell-free plasma, collected during neoadjuvant chemotherapy, including whole blood and cell-free plasma.
e
Includes cell-free plasma, collected between primary debulking and adjuvant chemotherapy.
f
Includes cell-free plasma, collected during adjuvant chemotherapy following primary debulking.

3
 H.S. Zelisse et al. Annals of Diagnostic Pathology 74 (2025) 152411

been previously assessed, and the complexities and potential pri-

• When developing the documents, avoid relying solely on the templates

requirements, and guidelines from all participating hospitals to ensure

of the coordinating center. Instead, compile and review all standards,
vacy risks involved in linking various internal and external data-

• Firstly, secure ethical approval for the biobank from the coordinating
comprehensive compliance and consideration of each center's ethical

center, allowing the review findings to be shared subsequently with

bases and registries [9]. In retrospect, involving the Data Protection
Officer and IT Security Officer during the early developing phase of
Secure approval for the biobank from each participating center

the IT infrastructure could have expedited the process by addressing

potential issues upfront, rather than after extensive planning.
Furthermore, their input during this phase can offer valuable in-
sights, potentially influencing both the overall infrastructure design

• Review committees from participating centers

and the choice of specific software.
To our knowledge, no existing consortium agreement template
specifically for multicenter biobanks was available when we
implemented the AOCR biobank. The drafting process, led by a
legal advisor at the coordinating center (Amsterdam UMC),
required harmonizing the agreement with the other eight con-

and operational criteria.

Comprehensive summary of the three significant challenges in the establishment of the AOCR biobank, accompanied by practical strategies to addressing these challenges.

sortium members. This proved to be time-intensive, involving an

iterative cycle of drafting, soliciting and processing feedback from
the consortium members, until consensus was reached. Currently,

other centers.
the consortium agreement of the AOCR biobank has been trans-
formed into several templates to provide guidance for future (in-
Review

ternational) multicenter biobanks [24]. The key elements included

in the consortium agreement of the AOCR are described in Table 2.
Following approval from Amsterdam UMC, the biobank docu-
significant differences exist, arrange a meeting to discuss and
• Provisions for the collection, storage, and issuance of samples

centers for their key priorities and foundational principles. If

• Provisions to ensure participant confidentiality and privacy.
• Terms and conditions for the issuance of samples and data.
• Governance structure detailing tasks and responsibilities of

mentation was submitted to the other 16 participating hospitals for

• Utilize an existing template, if available, to streamline the
Draft a consortium agreement, including, but not limited to:

• Include a standard Data Transfer Agreement and Material

agreements with each transfer of data and biomaterials

review. Unfortunately, the request to adapt these documents to the

• Before creating the first draft, consult the participating
• Clauses on ownership and intellectual property rights.

• Financial management and arrangement provisions.

unique templates of each hospital extended the overall duration of

Transfer Agreement, to avoid the need for separate
the biobank manager and the steering committee.

• Provisions for authorship and publication rights.

the review process. Apart from the approval of the coordinating

center, each hospital conducted its independent review, a necessary
step due to their individual responsibility for overseeing the bio-
• Legal advisor from participating centers
• Legal advisor from coordinating center

bank's operations within their respective institutions. This process

entailed that the same documents were reviewed by 17 different
between participating hospitals.

review committees in total, resulting in a substantial consumption

of time, resources, and effort. Some hospitals requested document
align these viewpoints.

modifications before approval, whereas our objective was to ensure

Consortium agreement

uniformity across all hospitals, particularly in the patient informed

drafting process.

consent form, which was eventually accepted by all hospitals.

and data.

3.2. Number of hospitals and patients

The AOCR biobank opened for inclusion in two hospitals in

December 2020, enrolling four patients (Fig. 1). By the end of 2021,
decision, rather than deferring assessment until
• Integrate the expertise of the IT Security Officer
Security Officer in the early planning stages of

five hospitals participated in the biobank, contributing to the in-

the completion of the entire IT infrastructure
and Data Protection Officer in the software
• An evaluation of data necessity relative to

• Engage the Data Protection Officer and IT

clusion of 182 patients that year. In 2022, the number of recruiting

selection process, particularly in cases of
• Determination of measures to minimize/
• Identification of potential privacy risks;

• Decision-making for GDPR compliance.

• Promptly assess selected software upon

hospitals increased to 11, enrolling 346 new patients. By the end of

the IT infrastructure of the biobank.
• An outline of data types processed;

2023, 17 hospitals actively recruited participants, enrolling 557

Data protection impact assessment

patients. Over three years, this cumulative effort resulted in the

inclusion of 1093 patients in the AOCR biobank. Of these, 70 %
Perform a DPIA, including:

• Data Protection Officer

consented to be approached for follow-up research. In comparison,

63.7 % agreed to share their data and biomaterials with foreign
• IT Security Officer

institutes that have privacy measures different from Dutch stan-

prevent risks;

uncertainty.

dards, and 57.7 % consented to issue to commercial parties.

objectives;

planning.

3.3. Clinicopathological characteristics

Data linkage between the AOCR and both the NCR and Palga
was initiated for all 532 patients included from 2020 to 2022
Required non-biobank-related personnel

(Fig. 2). Of these, nine patients (1.7 %) could not be linked to both
registries, resulting in successful linkage of 523 patients. Among
these, nine patients were included based on a recurrence. Further-
more, 127 patients (23.9 %) were found to have tumors that were
either non-malignant (n = 102) or of non-ovarian origin (n = 25).
This resulted in a cohort of 387 primary ovarian cancer patients for
whom clinical and pathological data were available.
Practical tips

The median age of the ovarian cancer patients was 66 years,

ranging from 24 to 84 years (Table 3). The majority of epithelial
Table 2

Tasks

ovarian cancer patients was diagnosed with high-grade serous

carcinoma (73.4 %), followed by endometrioid (6.7 %), low-grade

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H.S. Zelisse et al. Annals of Diagnostic Pathology 74 (2025) 152411

Fig. 1. Overview of the number of included patients per quartile, with the number of participating hospitals between brackets.

Fig. 2. Flowchart of the linkage process between the Archipelago of Ovarian Cancer Research (AOCR) biobank and Netherlands Cancer Registry (NCR) and the Dutch
nationwide pathology databank (Palga).

5
H.S. Zelisse et al. Annals of Diagnostic Pathology 74 (2025) 152411

Table 3 serous (5.7 %), clear cell (5.4 %) and mucinous carcinoma (2.8 %).
Clinicopathological characteristics of the patients included in the AOCR biobank Additionally, carcinosarcoma was diagnosed in 3.1 % of the cases. Early-
between 2020 and 2022. stage disease (FIGO I/II) was seen in 18.6 % of the patients, while 80.9 %
AOCR had advanced-stage disease (FIGO III/IV). Most patients underwent in-
n (%) terval debulking surgery (59.4 %), followed by primary debulking sur-
Patients 387 gery (19.6 %) and staging surgery (12.2 %). Other forms of surgery were
Age (years) Median: 66 (range: 24–84) performed in 1.8 % of the patients, while 7 % did not undergo surgery.
Histotype Of the patients undergoing debulking surgery, 80.7 % had no macro-
High-grade serous carcinoma 284 (73.4)
scopic disease post-surgery (complete debulking), 14.7 % had residual
Endometrioid carcinoma 26 (6.7)
Low-grade serous carcinoma 22 (5.7) disease up to 10 mm (optimal debulking), and 3.9 % had >10 mm of
Clear cell carcinoma 21 (5.4) residual disease (incomplete debulking). Chemotherapy was adminis-
Carcinosarcoma 12 (3.1) tered to 90.4 % of the patients.
Mucinous carcinoma 11 (2.8)
Serous carcinomaa 1 (0.3)
Undifferentiated carcinoma 1 (0.3)
3.4. Samples stored
Adenocarcinoma; histotype undetermined 6 (1.5)
Other histotype 3 (0.8)
FIGO stage Among the 1093 patients included, 3619 samples were collected.
I 46 (11.9) These comprised 18 preoperative biopsies, 19 preoperative ascites
II 26 (6.7) cellblocks, 1302 resection samples, 1604 preoperative blood samples,
III 193 (49.9)
IV 120 (31)
and 676 during-treatment blood samples. Of 532 patients (48.7 %),
Missing 2 (0.5) resection tissue was stored. Of the 1302 resection samples stored, 750
Type of surgery were stored as fresh-frozen (FF) samples, and 552 were stored as
Staging 47 (12.2) formalin-fixed paraffin-embedded (FFPE) blocks. Moreover, of 542 pa-
Primary debulking 76 (19.6)
tients at least one representative slide was scanned and uploaded. To
Interval debulking 230 (59.4)
Other 7 (1.8) date, no samples stored in the biobank have been recalled for clinical
None 27 (7) use.
Macroscopic disease after debulking Table 4 displays the number of patients with stored samples for
None 247 (80.7) whom clinicopathological data was available, categorized by treatment.
1-10 mm 45 (14.7)
>10 mm 12 (3.9)
Biopsy tissue and ascites were rarely collected (<2 %). Resection tissue
Missing 2 (0.7) was obtained in approximately 60 % of the patients, with FF tissue
Chemotherapy collected at a higher rate (55.6 %) compared to FFPE tissue (37.7 %).
Yes 350 (90.4) Among patients undergoing debulking surgery, FF resection tissue was
No 37 (9.6)
collected in about 60 % of cases, while FFPE tissue was collected in 27.6
a
Not classified as high- or low-grade. % of primary debulking patients and in nearly half of interval debulking
patients. In 65.6 % of cases, at least one slide was digitized. Baseline
blood samples were collected in 35.1 % of patients, with collection rates

Table 4
Overview of the number of patients with stored samples, stratified per treatment. aThe sum of FF and FFPE samples may exceed the total number of patients with tumor
tissue collected, as both types of samples could be collected from patients. bStored as a cellblock prepared using the agar cellblock method or CellientTM automated cell
block system. cIncludes serum, plasma, whole blood and cell-free plasma, collected before the start of treatment. dIncludes whole blood and cell-free plasma, collected
during neoadjuvant chemotherapy. eIncludes cell-free plasma, collected between primary debulking and adjuvant chemotherapy. fIncludes cell-free plasma, collected
during adjuvant chemotherapy following primary debulking. FF, fresh frozen; FFPE, formalin-fixed paraffin-embedded; N/A, not applicable; IDB, interval debulking;
PDB, primary debulking.
No Staging surgery, n Primary debulking surgery, Interval debulking surgery, Other surgery, n Total,
surgery, (%) (n=47) n (%) (n=76) n (%) (n=230) (%) (n=7) n (%)
n (%) (n=387)
(n=27)

Tumor tissue, treatment-

0 0 1 (1.3) 3 (1.3) 0 4 (1)
naïve (biopsy)a
FF 0 0 0 2 (0.9) 0 2 (0.5)
FFPE 0 0 1 (1.3) 1 (0.4) 0 2 (0.5)
Tissue Ascites, treatment-naïveb 0 0 2 (2.6) 3 (1.3) 0 5 (1.3)
Tumor tissue (surgery)a N/A 20 (42.6) 48 (63.2) 161 (70) 4 (47.1) 233 (60.2)
FF N/A 19 (40.4) 46 (60.5) 147 (63.9) 3 (42.9) 215 (55.6)
FFPE N/A 11 (23.4) 21 (27.6) 112 (48.7) 2 (28.6) 146 (37.7)
Digital slide N/A 31 (66) 47 (61.8) 170 (73.9) 6 (85.7) 254 (65.6)
Baselinec 10 (37) 30 (63.8) 41 (53.9) 50 (21.7) 5 (71.4) 136 (35.1)
preIDBd 7 (25.9) N/A N/A 155 (67.4) 2 (28.6) 164 (42.4)
Blood
postPDB1e N/A N/A 9 (11.8) N/A N/A 9 (2.3)
postPDB2f N/A N/A 6 (7.9) N/A N/A 6 (1.6)
a
The sum of FF and FFPE samples may exceed the total number of patients with tumor tissue collected, as both types of samples could be collected from patients.
b
Stored as a cellblock prepared using the agar cellblock method or Cellient™ automated cell block system.
c
Includes serum, plasma, whole blood and cell-free plasma, collected before the start of treatment.
d
Includes whole blood and cell-free plasma, collected during neoadjuvant chemotherapy.
e
Includes cell-free plasma, collected between primary debulking and adjuvant chemotherapy.
f
Includes cell-free plasma, collected during adjuvant chemotherapy following primary debulking.

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H.S. Zelisse et al. Annals of Diagnostic Pathology 74 (2025) 152411

of 63.8 % in staging surgery, 53.9 % in primary debulking surgery, and procedure leads to either staging surgery in early-stage or primary
21.7 % in interval debulking surgery. Pre-interval debulking blood debulking surgery in advanced-stage disease. Considering that treat-
samples were collected in 67.4 % of patients undergoing interval ment-naïve blood samples and tumor tissue resected during surgery are
debulking surgery. Post-primary debulking blood samples were stored, obtaining patient consent post-surgery is unfeasible. Conse-
collected in approximately 10 % of the patients. quently, the pre-surgical inclusion of these patients is critical to ensure
the collection and storage of their biomaterials. However, for tumor
4. Discussion types in which intraoperative frozen section analysis is not (routinely)
performed, pre-surgical inclusion is less relevant, as the diagnosis is
In 2019, the Archipelago of Ovarian Cancer Research (AOCR) was confirmed prior to surgery, allowing for more focused patient selection.
established as a Dutch multicenter, interdisciplinary infrastructure, Enrolling patients suspected of ovarian cancer also enables the
dedicated to improve treatment outcomes and survival rates for ovarian storage of pre-operative biopsy tissue and ascites. However, the storage
cancer by facilitating fundamental and translational ovarian cancer rates of pre-operative biopsy tissue and ascites are only 1 % and 1.3 %
research. Central to achieving this goal is the availability of high-quality respectively. This may result from these procedures often being per-
biomaterials with corresponding clinical and pathological details, formed in non-participating hospitals, followed by referral to partici-
making the AOCR biobank a crucial part of the infrastructure. pating hospitals. Additionally, there is often minimal or no residual
Throughout the establishment and review phase of the biobank, we tissue, particularly in biopsies. Moreover, the logistics for storing these
encountered challenges in securing approval for the DPIA, formulating a samples may not have been fully implemented. Considering this, it may
consortium agreement, and obtaining clearance from the review com- be beneficial to include patients who undergo pre-operative diagnostics
mittees of all participating hospitals. The insights gained from only after confirming an ovarian cancer diagnosis. This approach would
addressing these challenges can provide valuable guidance to others lead to fewer non-ovarian cancer patients in the AOCR biobank, and
establishing biobanks, therefore enhancing the efficiency and effec- enhance efficiency in terms of time and effort.
tiveness of the review process. Following approval, 1093 patients were In addition to the low storage rate of pre-operative tissue and ascites,
enrolled in the biobank in 17 hospitals from December 2020 to the collection of resection tissue presents additional challenges. Residual
December 2023. During this period, >3600 samples were collected, resection tissue has been stored in 48.7 % of the cases. However, it is
establishing a robust foundation for future research. important to note that the number of cases also includes patients with
Entities planning to establish a biobank in the Netherlands, but also benign or non-ovarian tumors, of whom samples are not stored. When
outside the Netherlands, may find considerable benefits in using the IT specifically examining patients with ovarian cancer included from 2020
infrastructure of the AOCR biobank as a template, as previously to 2022, the storage rate of resection tissue was 60.2 %. Besides the time
described [9]. By adopting this infrastructure, the already extensively required to properly establish the logistics, this low storage rate may be
reviewed DPIA can be used as template, which is available upon request attributed to the manual nature of the inquiry process for storing tissue
from the corresponding author. Moreover, the consortium agreement of for the AOCR. In most hospitals, this involves entering the request into
the AOCR biobank has been adapted into standardized templates to the general pathology enquiry. Automating this process could offer a
serve as a model for forthcoming multicenter biobank initiatives, of- solution. For instance, an automated system might send a storage order
fering valuable guidance and structure [24]. to the pathology inquiry when a patient enrolled in the biobank is
Initiating the approval process in a comprehensive and high-quality registered for surgery in the electronic patient record. However, this
manner at a single center proved beneficial, likely facilitating a more automation has not yet been implemented in our biobank. Additionally,
efficient review process at other centers. Moreover, it allowed us to refer certain procedural aspects within the pathology department may affect
to the initial approval as a basis for maintaining consistency in the the storage rate. For example, if the storage order is inadvertently
documents across other hospitals. However, further expediting this overlooked, the tissue could already be placed in formalin for fixation,
process seems unlikely. This would require guidelines or legislation precluding the possibility of storing fresh frozen tissue. Moreover, since
permitting approval by a single center, with other centers only con- FFPE blocks are typically created the day after surgery, prompt
ducting local assessments, as is the case in the Netherlands for research communication of storage orders is essential. From our experience,
under the Medical Research Involving Human Subjects Act [22]. adherence to established department-wide protocols, as well as the
From 2020 to 2023, 17 hospitals contributed to enrolling 1093 pa- oversight of a dedicated study support staff member within the pathol-
tients in the AOCR biobank. The total number of patients diagnosed with ogy department focusing on the sample storage process for the AOCR,
ovarian cancer during this period (excluding 2020, in which only four can maximize the numbers of samples stored.
patients were enrolled) was 4248 [7]. However, it is not possible to
determine the inclusion rate at this time, as inclusion began at different 5. Conclusion
time points across the hospitals, and the total number of ovarian cancer
cases diagnosed per individual hospital was not tracked. Additionally, In summary, the Dutch multicenter Archipelago of Ovarian Cancer
comparing the number of included patients to the overall incidence of Research biobank has achieved remarkable progress within a short time
ovarian cancer does not accurately reflect the inclusion rate, as the span of three years. By successfully enrolling 1093 patients across 17
AOCR biobank also included non-malignant and non-ovarian cancer hospitals, and collecting and storing a substantial number of 3619
cases. Therefore, a one-year inclusion rate can only be accurately samples, we have established a solid foundation for future fundamental
calculated once all hospitals have been open for inclusion for a full year and translational ovarian cancer research. However, the establishment
and the number of ovarian cancer patients among the total number of of the biobank has not been without challenges. These included
patients included in that year has been determined. obtaining clearance for the Data Protection Impact Assessment, drafting
Among the 523 patients linked with the NCR and Palga, 23.9 % were a consortium agreement, and gaining medical ethical approval from all
diagnosed with either a non-malignant tumor or a non-ovarian malig- participating hospitals. Furthermore, evaluation of the biobank has
nancy. The inclusion of these patients was possible due to the inclusion revealed opportunities for refinement, particularly in reducing the in-
criteria allowing the enrolment of patients suspected of having ovarian clusion of patients with a benign tumor or non-ovarian cancer, and in
cancer. We decided to include this patient group since a subset of enhancing sample storage rate. The experiences and challenges
ovarian cancer patients, particularly those suspected of early-stage dis- encountered during the establishment and implementation phases of the
ease, do not undergo diagnostic biopsy or cytological examinations biobank have provided valuable lessons. We have formulated practical
before surgery, but undergo exploratory surgery with intraoperative tips to address these issues. We believe these insights will be beneficial
frozen section analysis [25]. If ovarian cancer is confirmed, the and offer valuable guidance to other researchers embarking on similar

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H.S. Zelisse et al. Annals of Diagnostic Pathology 74 (2025) 152411

biobank projects in the future. Methodology, Funding acquisition, Conceptualization. Trudy G.N.
Jonges: Writing – review & editing, Methodology, Funding acquisition,
CRediT authorship contribution statement Conceptualization. Ronald P. Zweemer: Writing – review & editing,
Methodology, Funding acquisition, Conceptualization. Loes F.S.
Hein S. Zelisse: Writing – review & editing, Writing – original draft, Kooreman: Writing – review & editing, Methodology, Funding acqui-
Validation, Project administration, Methodology, Conceptualization. sition, Conceptualization. Sandrina Lambrechts: Writing – review &
Mignon D.J.M. van Gent: Writing – review & editing, Supervision, editing, Methodology, Funding acquisition, Conceptualization. Inge M.
Methodology, Funding acquisition, Conceptualization. Constantijne H. W. Ebisch: Writing – review & editing, Methodology, Funding acqui-
Mom: Writing – review & editing, Supervision, Methodology, Funding sition, Conceptualization. Ineke M. de Kievit van der Heijden: Writing
acquisition, Conceptualization. Sander de Ridder: Writing – review & – review & editing, Methodology, Funding acquisition, Conceptualiza-
editing, Methodology, Conceptualization. Malou L.H. Snijders: Writing tion. Quirinus J. Voorham: Writing – review & editing, Methodology,
– review & editing, Methodology, Conceptualization. Marlou Heeling: Funding acquisition, Conceptualization. Maaike A. van der Aa: Writing
Writing – review & editing, Methodology, Conceptualization. Matthijs – review & editing, Methodology, Funding acquisition, Conceptualiza-
Stoter: Writing – review & editing, Methodology, Conceptualization. tion. Jeroen A.M. Belien: Writing – review & editing, Methodology,
Annegien Broeks: Writing – review & editing, Methodology, Funding Funding acquisition, Conceptualization. Marc J. van de Vijver: Writing
acquisition, Conceptualization. Hugo M. Horlings: Writing – review & – review & editing, Supervision, Methodology, Funding acquisition,
editing, Methodology, Funding acquisition, Conceptualization. Chris- Conceptualization. Frederike Dijk: Writing – review & editing, Super-
tianne A.R. Lok: Writing – review & editing, Methodology, Funding vision, Methodology, Funding acquisition, Conceptualization.
acquisition, Conceptualization. Steven L. Bosch: Writing – review &
editing, Methodology, Funding acquisition, Conceptualization. Jurgen Patient consent statement
M. Piek: Writing – review & editing, Methodology, Funding acquisition,
Conceptualization. Joost Bart: Writing – review & editing, Methodol- All patients in the Archipelago of Ovarian Cancer Research biobank
ogy, Funding acquisition, Conceptualization. Anna K.L. Reyners: gave informed consent for research with their data and biomaterials, and
Writing – review & editing, Methodology, Funding acquisition, linkage to external parties including the Netherlands Cancer Registry
Conceptualization. G. Bea A. Wisman: Writing – review & editing, (NCR), operated by the Netherlands Comprehensive Cancer Organisa-
Methodology, Funding acquisition, Conceptualization. Refika Yigit: tion (IKNL), and the Dutch nationwide pathology databank (Palga). Due
Writing – review & editing, Methodology, Formal analysis, Conceptu- to the retrospective and anonymous nature of data collection and
alization. Ingrid A. Boere: Writing – review & editing, Methodology, analysis, patient consent for the nationwide Dutch ovarian cancer cohort
Funding acquisition, Conceptualization. Margriet Collée: Writing – was not required.
review & editing, Methodology, Funding acquisition, Conceptualization.
Floris H. Groenendijk: Writing – review & editing, Methodology, Ethics approval
Funding acquisition, Conceptualization. Maurice P.H.M. Jansen:
Writing – review & editing, Methodology, Funding acquisition, The executive board of the Medical Research Ethics Committee of the
Conceptualization. Eva-Maria Roes: Writing – review & editing, Amsterdam UMC, location Amsterdam Medical Center (University of
Methodology, Funding acquisition, Conceptualization. Ward Hofhuis: Amsterdam), determined that the AOCR biobank is not subject to the
Writing – review & editing, Methodology, Funding acquisition, Dutch Directive on Medical Research Involving Human Subjects (refer-
Conceptualization. Klaas J. Hoogduin: Writing – review & editing, ence: W20_083) [8,22]. The Biobank Review Committee of the
Methodology, Funding acquisition, Conceptualization. Luthy S.M. Amsterdam UMC, location Amsterdam Medical Center (University of
Alcalá: Writing – review & editing, Methodology, Funding acquisition, Amsterdam), granted approval for the establishment of the AOCR bio-
Conceptualization. Huberdina P.M. Smedts: Writing – review & edit- bank (reference: 2019_272). Subsequently, the Medical Research Ethics
ing, Methodology, Funding acquisition, Conceptualization. Alexander Committee, Biobank Review Committee, or Institutional Review Board
C.F. Makkus: Writing – review & editing, Methodology, Funding of each participating hospital approved the local establishment of the
acquisition, Conceptualization. Gatske M. Nieuwenhuyzen-de Boer: biobank [8]. The AOCR biobank protocols are in accordance with the
Writing – review & editing, Methodology, Funding acquisition, Declaration of Helsinki [23]. Additionally, the issuance of data for this
Conceptualization. Nicole van Es: Writing – review & editing, Meth- study was approved by the scientific and privacy boards of the NCR and
odology, Funding acquisition, Conceptualization. Peggy M.L.H. Ven- Palga. All data retrieval and handling procedures adhered to the General
cken: Writing – review & editing, Methodology, Funding acquisition, Data Protection Regulation Act (GDPR) [17].
Conceptualization. Anne M. van Altena: Writing – review & editing,
Methodology, Funding acquisition, Conceptualization. Michiel Simons: Funding
Writing – review & editing, Methodology, Funding acquisition,
Conceptualization. Hans Marten Hazelbag: Writing – review & editing, This work was supported by Dutch Cancer Society [grant number
Methodology, Funding acquisition, Conceptualization. Marjolein J. 11774].
Kagie: Writing – review & editing, Methodology, Funding acquisition,
Conceptualization. Riena Aliredjo: Writing – review & editing, Meth- Declaration of competing interest
odology, Funding acquisition, Conceptualization. Tijmen J.J. Bone-
stroo: Writing – review & editing, Methodology, Funding acquisition, The authors have no competing interests to declare that are relevant
Conceptualization. Tjalling Bosse: Writing – review & editing, Meth- to the content of this article.
odology, Funding acquisition, Conceptualization. Cor D. de Kroon:
Writing – review & editing, Methodology, Funding acquisition, Acknowledgements
Conceptualization. Mariël Brinkhuis: Writing – review & editing,
Methodology, Funding acquisition, Conceptualization. Marc-Jan We thank all research technicians, research nurses and other staff
Janssen: Writing – review & editing, Methodology, Funding acquisi- who contributed to the establishment and implementation of the Ar-
tion, Conceptualization. Nils C. Koster: Writing – review & editing, chipelago of Ovarian Cancer Research infrastructure and biobank. We
Methodology, Funding acquisition, Conceptualization. Arnold-Jan thank S.Y.M. van der Heijden, L.L.M., Legal Counsel Amsterdam UMC,
Kruse: Writing – review & editing, Methodology, Funding acquisition, location Academic Medical Center for her extensive legal contribution.
Conceptualization. Cornelis G. Gerestein: Writing – review & editing, We thank all collaborating parties. We thank all patients who participate

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H.S. Zelisse et al. Annals of Diagnostic Pathology 74 (2025) 152411

and all patients who are going to participate in the Archipelago biobank. Biobank: A Potential Blueprint for Other Biobanks. Biopreserv Biobank 2024.
https://doi.org/10.1089/bio.2023.0118 [Epub ahead of print].
We thank the Dutch Cancer Society for supporting this work [grant
[10] Lheureux S, Braunstein M, Oza AM. Epithelial ovarian cancer: evolution of
number 11774]. management in the era of precision medicine. CA Cancer J Clin 2019;69(4):
280–304.
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pathology, biology, and disease models. Front Biosci (Landmark Ed) 2009;14(6):
2089–102.
The data analyzed in the current study are not publicly available [12] Cook DP, Vanderhyden BC. Ovarian cancer and the evolution of subtype
because these data were collected and issued by third parties, namely classifications using transcriptional profiling†. Biol Reprod 2019;101(3):645–58.
[13] Califano D, Russo D, Scognamiglio G, Losito NS, Spina A, Bello AM, et al. Ovarian
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parties. Issue of biomaterials from the Archipelago of Ovarian Cancer [15] Health-RI. Het belang van harmoniseren van biobank procedures 2023 [13-02-
Research can be requested via aocr@amsterdamumc.nl. 2024]. Available from: https://www.health-ri.nl/nieuws/het-belang-van-harmon
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[16] Dutch Ministry of Justice and Security. Uitvoeringswet Algemene verordening
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