Risks of Breast, Ovarian, and Contralateral Breast Cancer for BRCA1 and BRCA2 Mutation Carriers.
Karoline B Kuchenbaecker, John L Hopper, Daniel R Barnes...
https://pubmed.ncbi.nlm.nih.gov/28632866Actively Recruiting
Age: 18Years +
FEMALE
ID07532434
A Bidirectional Cohort Study on Prophylactic Resection Surgery in Women at Moderate-to-High Genetic Risk for Hereditary Ovarian Cancer
Led by Peking University Third Hospital · Updated on 2026-04-15
480
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women who have a moderate-to-high genetic risk for hereditary ovarian cancer to understand how different preventive surgical options work and how safe they are. They aim to compare individualized preventive surgeries, like removing fallopian tubes now and delaying ovary removal, against standard care or close monitoring to see which best reduces ovarian cancer risk. The study also looks at how these surgeries affect ovarian function and quality of life. The study follows women who carry specific gene mutations such as BRCA1, BRCA2, RAD51C, and others. Participants choose one of three paths with their doctors: standard risk-reducing surgery removing both fallopian tubes and ovaries at once (RRSO), removing fallopian tubes first and delaying ovary removal (RS-DO), or close monitoring with ultrasound and blood tests if they decline surgery. The study includes both past data from 2020 onward and new participants, with follow-up planned for at least 3 years. Participants will have their clinical data collected, including surgical pathology reviewed centrally to detect early signs of cancer. They will complete quality of life and psychological assessments over time. Researchers will track ovarian, fallopian tube, and peritoneal cancer incidence as the main outcome over up to 15 years. Safety, quality of life, menopausal symptoms, and psychological distress are also monitored. The study uses strict data validation and regular audits to ensure accuracy.
CONDITIONS
Brief Title
A Bidirectional Cohort Study on Prophylactic Resection Surgery in Populations at Moderate-to-High Risk for Hereditary Ovarian Cancer
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female gender, age 18 years or older at enrollment
- Documented carriers of pathogenic or likely pathogenic germline mutations in high-risk ovarian cancer susceptibility genes (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2)
- Willingness to provide informed consent and allow access to clinical records, genetic testing reports, and follow-up data
- Ability to complete quality of life and psychological assessment scales such as GCS, SF-36, FSFI
You will not qualify if you...
- History of ovarian, fallopian tube, or primary peritoneal cancer before baseline intervention
- Diagnosis of any other advanced-stage malignancy
- Significant psychological, social, or geographical factors preventing regular long-term follow-up for at least 3 years
- Previous extensive pelvic surgery that makes laparoscopic prophylactic salpingectomy or oophorectomy not feasible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo prophylactic surgery based on their assigned group: concurrent bilateral salpingo-oophorectomy (RRSO), salpingectomy with delayed oophorectomy (RS-DO), or decline surgery and start close monitoring.
1 surgical visit
Post-operative Follow-up
Duration - Up to 1 year
Participants who had surgery receive follow-up care including pathology review for occult cancer and assessments of menopausal symptoms and quality of life.
Visits at baseline, 1 month, 6 months, and 1 year post-surgery or enrollment
Long-term Monitoring
Duration - Up to 15 years
Participants are followed for up to 15 years to monitor for the incidence of ovarian cancer and breast cancer, with regular assessments for those in the close monitoring group involving ultrasound and biomarker testing.
Regular monitoring visits every 6 to 12 months depending on group assignment
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
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Research Team
A
Associate Chief Physician/Associate Consultant, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Alexandra Lukey, A Fuchsia Howard, Alice J Mei...
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Eric Leblanc, Fabrice Narducci, Gwenaël Ferron...
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Jacqueline Sia, Emily F Lane, Caitlin T Fierheller...
https://pubmed.ncbi.nlm.nih.gov/40956577TUBectomy 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.
Miranda P Steenbeek, Majke H D van Bommel, Joanna intHout...
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Mary B Daly, Tuya Pal, Michael P Berry...
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Fergus J Couch, Hermela Shimelis, Chunling Hu...
https://pubmed.ncbi.nlm.nih.gov/28418444BRCA1 and BRCA2 mutations account for a large proportion of ovarian carcinoma cases.
Tuya Pal, Jenny Permuth-Wey, Judith A Betts...
https://pubmed.ncbi.nlm.nih.gov/16284991