NCT02321228Active, not recruiting
Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers
Early Salpingectomy (Tubectomy) With Delayed Oophorectomy to Improve Quality of Life as Alternative for Risk Reducing Salpingo-oophorectomy in BRCA1/2 Gene Mutation Carriers
Source: ClinicalTrials.gov · Last updated 5 Dec 2024
Brief summary (registry, in English)
The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 510 (estimated)
- First submitted
- 11 Dec 2014
- Start date
- Jan 2015
- Primary completion date
- Jan 2030
- Lead sponsor
- University Medical Center Nijmegen
- Diseases
- Ovarian cancer
- NCT number
- NCT02321228
What you commit to
- Study type: Interventional
- Planned participants: 510
- From Jan 2015 to the primary completion date, Jan 2030
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior bilateral salpingectomy
Other illness
- Postmenopausal status (natural menopause or due to (cancer) treatment)
- A personal history of ovarian, fallopian tube or peritoneal cancer
- Evidence of malignant disease at enrollment
- Treatment for malignant disease at enrollment
Age
- Inability to read or speak Dutch
- BRCA mutation carriers who opt for salpingectomy but who do not want to postpone the oophorectomy beyond the guideline age will undergo similar follow-up but do not contribute to the 510 inclusions we need
Other
- Wish for second stage oophorectomy within two years after salpingectomy (if clear at enrollment)
- Legally incapable
Who the study is looking for
- Premenopausal women with a documented BRCA1 and/or BRCA2 germline mutation
- Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2
- Childbearing completed
- Presence of at least one fallopian tube
- Participants may have a personal history of non-ovarian malignancy
Age in the registry: 25 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Academic Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| VU University Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Catharina hospital Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Medical Center Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Unknown status |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Elisabeth-TweeSteden Hospital Coordinator of this site? Confirm its status | Tilburg | Netherlands | Unknown status |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Maxima Medical Center Coordinator of this site? Confirm its status | Veldhoven | Netherlands | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.