NCT01907789Active, not recruiting
Prophylactic Salpingectomy With Delayed Oophorectomy
Prophylactic Salpingectomy With Delayed Oophorectomy, Risk-Reducing Salpingo-Oophorectomy, and Ovarian Cancer Screening Among BRCA Mutation Carriers: A Proof-of-Concept Study
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
The goal of this clinical research study is to compare ovarian cancer screening, risk-reducing salpingo-oophorectomy (RRSO), and prophylactic salpingectomy with delayed oophorectomy (PSDO). The safety of RRSO and PSDO will also be studied. Ovarian cancer screening does not involve a surgical procedure. Instead, physical exams, blood tests, and ultrasound are used to check for ovarian, fallopian tube, and peritoneal cancer. The surgical procedures, RRSO and PSDO, are designed to lower your risk of ovarian cancer. In RRSO, the fallopian tubes and ovaries are removed at the same time. In PSDO, the fallopian tubes are removed and the ovaries remain in place so that the patient does not go through menopause. The ovaries are removed at a later date. The main goal of this study is to learn how many patients actually have their ovaries removed at a later date. Researchers also want to learn whether the removal of fallopian tubes will decrease the risk of ovarian cancer.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 18 Jul 2013
- Start date
- 26 Aug 2013
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Ovarian cancer
- NCT number
- NCT01907789
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 26 Aug 2013 to the primary completion date, 31 Dec 2030
- 2 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
- Medical comorbidities making surgery unsafe as determined by the patient's surgeon.
- Prior bilateral salpingectomy. Prior unilateral salpingectomy is allowed.
Other illness
- Women with a history of ovarian, fallopian tube, or primary peritoneal cancer.
- Women currently undergoing cancer treatment or with a known active cancer. History of malignancy is allowed as long as the patient has completed treatment \> 3 months prior to enrollment.
- Women whose most recent CA125 or transvaginal ultrasound is abnormal. A history of abnormal CA125 or ultrasound is allowed, as long as the most recent testing is normal.
Age
- Postmenopausal women or women \< 30 or \>/= 48 years of age.
Other
- Women without a documented BRCA mutation.
- Women who are pregnant. Patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta HCG, or best judgement of the investigator. Pregnancy testing is not required per protocol to determine study eligibility.
- Women desiring future fertility except in the screening arm of the trial.
- Inability to provide informed consent.
- Inability to read or speak English.
Who the study is looking for
- Premenopausal women with a documented BRCA1 or BRCA2 mutation. Menopause is defined as \>/= 12 months of amenorrhea.
- Women must be at least 30 and less than 48 years of age.
- Candidate for surgery and willing to undergo two surgical procedures (if chooses the PSDO arm).
- Patient choosing PSDO or RRSO must desire permanent sterilization.
- Presence of at least one fallopian tube. Prior tubal ligation is allowed.
- Participants may have a personal history of non-ovarian malignancy, but must be without evidence of disease at enrollment and the patient must have completed treatment (including surgery, chemotherapy, or radiotherapy) \> 3 months prior to enrollment (other than non-melanoma skin cancer). Current or past SERM or aromatase inhibitor use is allowed.
- Willingness to return to the enrolling site for any surgical procedures including pre-operative and post-operative care.
- Willingness to return to the enrolling site for ovarian cancer screening during the study period.
Age in the registry: 30 years to 47 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northshore University Health System Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.