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Prevention study for BRCA1 Gene Mutation
Official title TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
ClinicalTrials.gov ID: NCT04294927
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 50, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Richmon, Victoria, Australia
- St Albans, Victoria, Australia
- Perth, Western Australia, Australia
- Brisbane, Australia
- Melbourne, Australia
- Graz, Austria
- Brussels, Belgium
+ 36 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 25 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; St Louis, Missouri, United States; New York, New York, United States; Durham, North Carolina, United States and 50 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.