BRCA1 Gene MutationTUBA-WISP-IINCT04294927
TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
A study testing Risk-reducing salpingectomy with delayed oophorectomy and Risk-reducing salpingo-oophorectomy in people with BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by University Medical Center Nijmegen at 66 sites in 16 countries.
Trial summary
The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- BRCA1 Gene Mutation, BRCA2 Gene Mutation, RAD51C Gene Mutation
- What is being tested?
- Risk-reducing salpingectomy with delayed oophorectomy and Risk-reducing salpingo-oophorectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 66 sitesin 16 countries
- Study dates
- 1 Mar 2020to 17 Feb 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
- Age at inclusion;
- BRCA1: 25-40 years
- BRCA2: 25-45 years
- RAD51C, RAD51D, BRIP1: 25-50 years
- Childbearing completed
Show all 9Show fewer
- Presence of at least one fallopian tube
- Participants may have a personal history of non-ovarian malignancy
- Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.
Who cannot join
- Postmenopausal status (natural menopause or due to treatment)
- Wish for second stage RRO within two years after RRS
- Legally incapable
- Prior bilateral salpingectomy
- A personal history of ovarian, fallopian tube or peritoneal cancer
- Current diagnosis or treatment for malignant disease
Trial locations and contacts
66 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
66 sites in 16 countries
Australia15 sites, 15 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Ngaire Latch, +61870740000, ngaire.latch@unimelb.edu.au
- Recruiting
St Andrew War Memorial Hospital
Brisbane, Queensland, 4001
Ngaire Latch, +61738344444, ngaire.latch@unimelb.edu.au
- Recruiting
Royal Brisbane Hospital
Brisbane, Queensland, 4006
Ngaire Latch, +61736468111, ngaire.latch@unimelb.edu.au
- Recruiting
Greenslopes Private Hospital
Brisbane, Queensland, 4120
Ngaire Latch, +61733947111, ngaire.latch@unimelb.edu.au
- Recruiting
The Mater Hospital
Brisbane
Ngaire Latch, +61394266666, ngaire.latch@unimelb.edu.au
- Recruiting
Frances Perry House
Melbourne, Victoria, 3050
Ngaire Latch, +61393445000, ngaire.latch@unimelb.edu.au
- Recruiting
Mercy Hospital
Melbourne, Victoria, 3084
Ngaire Latch, +61 3 8458 4444, ngaire.latch@unimelb.edu.au
- Recruiting
Monash Health
Melbourne
Martha Hickey
- Recruiting
Peter MacCallum Centre
Melbourne
Martha Hickey
- Recruiting
Royal Womens Hospital
Melbourne
Martha Hickey
- Recruiting
King Edward Memorial Hospital
Perth, Western Australia, 6008
Ngaire Latch, +61864582222, ngaire.latch@unimelb.edu.au
- Recruiting
Epworth Hospital
Richmon, Victoria, 3121
Ngaire Latch, +61394266666, ngaire.latch@unimelb.edu.au
- Recruiting
Western Health
St Albans, Victoria, 3021
Ngaire Latch, 03 8345 1333, ngaire.latch@unimelb.edu.au
- Recruiting
Chris O'Brien Lifehouse
Sydney, New South Wales, 2050
Ngaire Latch, +61285140000, ngaire.latch@unimelb.edu.au
- Recruiting
Westmead hospital
Sydney, New South Wales, 2145
Ngaire Latch, +61288905555, ngaire.latch@unimelb.edu.au
Netherlands15 sites, 15 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam
Luc van Lonkhuijzen, MD, PhD
- Recruiting
Antoni van Leeuwenhoek
Amsterdam
Teska Schuurman, MD, PhD
- Recruiting
Amphia
Breda
Janneke Hoogstad, MD, PhD
- Recruiting
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Jurgen M.J. Piek, MD, PhD, jurgen.piek@catharinaziekenhuis.nl
- Recruiting
Medisch Spectrum Twente
Enschede
Nathalie Reesink-Peters, MD, PhD
- Recruiting
University Medical Center Groningen
Groningen
Marise Wagener, MD, PhD
- Recruiting
Medical Center Leeuwarden
Leeuwarden
Mirjam Apperloo, MD, PhD
- Recruiting
Leiden University Medical Center
Leiden
Katja Gaarenstroom, MD, PhD
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg
Brigitte Slangen, MD, PhD
- Recruiting
Radboudumc
Nijmegen, Gelderland
Joanne A. de Hullu, MD, PhD, +31 (0) 24 36 16683, Joanne.deHullu@radboudumc.nl
- Recruiting
Erasmus Medical Center
Rotterdam
Eva Roes, MD, PhD
- Recruiting
Elisabeth-TweeSteden Ziekenhuis
Tilburg, North Brabant
Caroline Vos, MD
- Recruiting
University Medical Center Utrecht
Utrecht
Ronald Zweemer, Prof, MD, PhD
- Recruiting
Maxima Medical Center
Veldhoven
Sjors Coppus, MD, PhD
- Recruiting
Isala Klinieken
Zwolle
Arnold-Jan Kruse, MD, PhD
United States11 sites, 11 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Karen Lu
- Recruiting
UChicago Medicine
Chicago, Illinois, 60637
Kathryn Mills
- Recruiting
Duke University Hospital
Durham, North Carolina, 27705
Haley Moss
- Recruiting
Harris Health Lyndon B. Johnson Hospital
Houston, Texas, 77026
Michaela Onstad-Grinsfelder
- Recruiting
MD Anderson Cancer Centre
Houston, Texas, 77030-4009
Karen Lu
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Stephanie Blank
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Kara Long Roche
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Sarah Kim
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Karen Lu
- Recruiting
University of Washington
Seattle, Washington, 98195
Elizabeth Swisher
- Recruiting
Washington University Medical Center
St Louis, Missouri, 63110
Andrea Hagemann
Germany4 sites, 4 recruiting
- Not yet recruiting
Klinikum St. Marien Amberg
Amberg
Thomas Papathemelis
- Recruiting
Evangelische Waldkrankenhaus Spandau Berlin
Berlin-Spandau
Katharina Carrizo
- Not yet recruiting
Klinikum Lippe Detmold
Detmold
Beyhan Ataseven
- Recruiting
Evang. Kliniken Essen-Mitte
Essen
Philipp Harter
Italy4 sites, 4 recruiting
- Recruiting
Universita di Bologna
Bologna
Myriam Perrone
- Recruiting
Humanitas San Pio X
Milan
Fabio Martinelli
- Recruiting
San Gerardo Hospital
Monza
Robert Fruscio
- Recruiting
Gemelli Hospital
Rome
Claudia Marchetti
Poland4 sites, 4 recruiting
- Recruiting
Gdynia Oncology Centre
Gdynia
Maciej Stukan
- Recruiting
Bonifraterskie Centrum Medyczne
Katowice
Monika Bodjys-Szyndlar
- Recruiting
Medical University of Silesia
Katowice
Krzysztof Nowosielski
- Recruiting
National Cancer Institute Warsaw
Warsaw
Agnieszka Rychlik
Norway3 sites, 2 recruiting
- Active, not recruiting
Akershus University Hospital
Nordbyhagen
- Recruiting
Oslo University Hospital
Oslo
Anne Dorum
- Recruiting
Stavanger Uniersity Hospital
Stavanger
Anne Dorum
Belgium2 sites, 2 recruiting
- Recruiting
Hopital Universitaire Bruxelles
Brussels
Maxime Fastrez
- Recruiting
Universitair Ziekenhuis Leuven
Leuven
Susanne Housmans
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz
Karl Tamussino
Brazil1 site, 1 recruiting
- Recruiting
AC Camargo Cancer Centre
São Paulo
Glauco Baiocchi
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver
Janice Kwon
Ireland1 site, 1 recruiting
- Recruiting
Cork University Hospital
Cork
Zibi Marchoki
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cancerología
Mexico City
David Cantu
Spain1 site, 1 recruiting
- Recruiting
Vall D'Hebron Barcelona
Barcelona
Judith Balmana
Sweden1 site, 1 recruiting
- Recruiting
Karolinksa Institutet
Stockholm
Angelique Flöter-Radestad
Uruguay1 site, 1 recruiting
- Recruiting
Hospital Británico
Montevideo
Santiago Scasso
About this study
Official title: TUBectomy With Delayed Oophorectomy as Alternative for Risk-reducing Salpingo-oophorectomy in High Risk Women to Assess the Safety of Prevention: TUBA-WISP II Study.
The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.
Read the detailed description
In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high. Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO). However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.
- Conditions
- BRCA1 Gene Mutation, BRCA2 Gene Mutation, RAD51C Gene Mutation, RAD51D Gene Mutation, BRIP1 Gene Mutation, Ovarian Cancer
- Being tested
- Risk-reducing salpingectomy with delayed oophorectomy, Risk-reducing salpingo-oophorectomy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-reducing salpingectomy with delayed oophorectomyProcedure or surgery
- BRCA1: RRS at age 25-40 and RRO at a maximum age of 45 (advised between 35 and 45).
- BRCA2: RRS at age 25-45 and RRO at a maximum age of 50 (advised between age 40 and 50).
- BRIP1, RAD51C, RAD51D: RRS at age 25-50 and RRO at a maximum age of 55 (advised between 45 and 55)
Risk-reducing salpingo-oophorectomyProcedure or surgery
- BRCA1 at a maximum age of 40 (advised between age 35 and 40)
- BRCA2 at a maximum age of 45 (advised between age 40 and 45)
- BRIP1, RAD51C, RAD51D: at a maximum age of 50 (advised between 45 and 50)
| Study group | Role | What they receive |
|---|---|---|
| Risk-reducing salpingectomy with delayed oophorectomy | Experimental | Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy. Receives: Procedure: Risk-reducing salpingectomy with delayed oophorectomy |
| Risk-reducing salpingo-oophorectomy | Active comparator | Risk-reducing salpingo-oophorectomy. Receives: Procedure: Risk-reducing salpingo-oophorectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
High grade serous (ovarian) cancer incidence
High grade serous (ovarian) cancer incidence
Measured: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
Secondary outcomes (5)
Incidence of (pre)malignant findings in tubes/ovaries
Incidence of (pre)malignant findings in tubes/ovaries at risk-reducing salpingectomy, oophorectomy and salpingo-oophorectomy.
Measured: 6 weeks after each surgery
Peri-operative morbidity and mortality
Peri-operative morbidity and mortality
Measured: 6 weeks after each surgery
Incidence of pelvic cancer (other than ovarian cancer)
Incidence of pelvic cancer (other than ovarian cancer)
Measured: Up to the age of 70
Incidence of breast cancer
Incidence of breast cancer
Measured: Up to the age of 70
Uptake of risk reducing oophorectomy
Uptake of risk reducing oophorectomy after risk reducing salpingectomy
Measured: Up to the age of 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Mar 2020
- Primary completion17 Feb 2040 (estimated)
- Study completion17 Feb 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BRCA1 Gene MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen
- Investigators
- Joanne A. de Hullu, MD, PhD, Principal investigator, Radboud University Medical CenterKaren H. Lu, MD, PhD, Principal investigator, M.D. Anderson Cancer CenterRosella P.M.G. Hermens, MD,PhD, Principal investigator, Radboud University Medical CenterElizabeth M. Swisher, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294927
- Sponsor's protocol ID
- NL 70691.091.19
- Acronym
- TUBA-WISP-II
- Status last verified
- Oct 2025
- First submitted
- 1 Mar 2020
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pennington KP, Pugh SL, Huh W, Walker JL, Jewell E, Havrilesky LJ, Carter J, Muller CY, Drapkin R, Lankes HA, Castellano T, Zamorano AS, Blank SV, Kachnic LA. Optimization of Timing for Risk-Reducing Salpingectomy and Oophorectomy. Obstet Gynecol. 2025 Jan 1;145(1):21-30. doi: 10.1097/AOG.0000000000005781. Epub 2024 Nov 7.
PubMed 39509704Steenbeek MP, van Bommel MHD, intHout J, Peterson CB, Simons M, Roes KCB, Kets M, Norquist BM, Swisher EM, Hermens RPMG; TUBA-WISP II consortium; Lu KH, de Hullu JA. TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol. Int J Gynecol Cancer. 2023 Jun 5;33(6):982-987. doi: 10.1136/ijgc-2023-004377.
PubMed 37045546
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TUBectomy With Delayed Oophorectomy as Alternative for Risk-reducing Salpingo-oophorectomy in High Risk Women to Assess the Safety of Prevention: TUBA-WISP II Study.
- ClinicalTrials.gov ID
- NCT04294927
- Acronym / sponsor ID
- TUBA-WISP-II / NL 70691.091.19
- Conditions
- BRCA1 Gene Mutation, BRCA2 Gene Mutation, RAD51C Gene Mutation, RAD51D Gene Mutation, BRIP1 Gene Mutation, Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 17 Feb 2040 (estimated)
- Study completion
- 17 Feb 2040 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.
Detailed description
In BRCA1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (RRSO) is recommended around the age of 40. This recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. Moreover, the mortality rate of ovarian cancer is high. Effects of RRSO are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. The fifty percent breast cancer risk reduction after RRSO has become disputable in the last years. Based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the Fallopian tube, an innovative strategy for RRSO has been developed for this study proposal: risk-reducing salpingectomy (RRS) with delayed risk-reducing oophorectomy (RRO). However, the safety of this strategy has not been proven yet. Before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk-reducing salpingectomy with delayed oophorectomy | Experimental | Procedure: Risk-reducing salpingectomy with delayed oophorectomyRisk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy. |
| Risk-reducing salpingo-oophorectomy | Active comparator | Procedure: Risk-reducing salpingo-oophorectomyRisk-reducing salpingo-oophorectomy. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
- Age at inclusion;
- Childbearing completed
- Presence of at least one fallopian tube
- Participants may have a personal history of non-ovarian malignancy
Key exclusion criteria (6 listed)
- Postmenopausal status (natural menopause or due to treatment)
- Wish for second stage RRO within two years after RRS
- Legally incapable
- Prior bilateral salpingectomy
- A personal history of ovarian, fallopian tube or peritoneal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-reducing salpingectomy with delayed oophorectomy* BRCA1: RRS at age 25-40 and RRO at a maximum age of 45 (advised between 35 and 45). * BRCA2: RRS at age 25-45 and RRO at a maximum age of 50 (advised between age 40 and 50). * BRIP1, RAD51C, RAD51D: RRS at age 25-50 and RRO at a maximum age of 55 (advised between 45 and 55) | Procedure or surgery | Risk-reducing salpingectomy with delayed oophorectomy |
| Risk-reducing salpingo-oophorectomy* BRCA1 at a maximum age of 40 (advised between age 35 and 40) * BRCA2 at a maximum age of 45 (advised between age 40 and 45) * BRIP1, RAD51C, RAD51D: at a maximum age of 50 (advised between 45 and 50) | Procedure or surgery | Risk-reducing salpingo-oophorectomy |
Primary outcome
High grade serous (ovarian) cancer incidence
Time frame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
High grade serous (ovarian) cancer incidence
5 secondary outcomes
Incidence of (pre)malignant findings in tubes/ovaries
Time frame: 6 weeks after each surgery
Peri-operative morbidity and mortality
Time frame: 6 weeks after each surgery
Incidence of pelvic cancer (other than ovarian cancer)
Time frame: Up to the age of 70
Incidence of breast cancer
Time frame: Up to the age of 70
Uptake of risk reducing oophorectomy
Time frame: Up to the age of 70
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 39509704Pennington KP, Pugh SL, Huh W, Walker JL, Jewell E, Havrilesky LJ, Carter J, Muller CY, Drapkin R, Lankes HA, Castellano T, Zamorano AS, Blank SV, Kachnic LA. Optimization of Timing for Risk-Reducing Salpingectomy and Oophorectomy. Obstet Gynecol. 2025 Jan 1;145(1):21-30. doi: 10.1097/AOG.0000000000005781. Epub 2024 Nov 7.
- Derived from this study: PubMed 37045546Steenbeek MP, van Bommel MHD, intHout J, Peterson CB, Simons M, Roes KCB, Kets M, Norquist BM, Swisher EM, Hermens RPMG; TUBA-WISP II consortium; Lu KH, de Hullu JA. TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol. Int J Gynecol Cancer. 2023 Jun 5;33(6):982-987. doi: 10.1136/ijgc-2023-004377.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joanne A. de Hullu, MD, PhD principal investigator
Radboud University Medical Center
Karen H. Lu, MD, PhD principal investigator
M.D. Anderson Cancer Center
Rosella P.M.G. Hermens, MD,PhD principal investigator
Radboud University Medical Center
66 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk-reducing salpingectomy with delayed oophorectomy and Risk-reducing salpingo-oophorectomy in people with BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by University Medical Center Nijmegen at 66 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Australia, Netherlands, United States, Germany, Italy and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanne A. de Hullu, MD, PhD (+31 (0) 24 36 16683, Joanne.deHullu@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High grade serous (ovarian) cancer incidence (time frame: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294927, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.