Prophylactic Salpingectomy With Delayed Oophorectomy
2 other identifiers
interventional
80
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2013
CompletedFirst Posted
Study publicly available on registry
July 25, 2013
CompletedStudy Start
First participant enrolled
August 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 16, 2026
April 1, 2026
17.4 years
July 18, 2013
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Compliance with Prophylactic Salpingectomy with Delayed Oophorectomy Strategy
The proportion of women who comply with the prophylactic salpingectomy with delayed oophorectomy strategy estimated with an exact 95% binomial confidence interval. If all 20 patients return for their scheduled oophorectomy the 95% confidence interval for the proportion of women who are compliant will be 0.846 to 1.00.
Up to 5 years
Secondary Outcomes (4)
Number of occult malignancies
Up to 5 years
Number of complications
Up to 5 years
Type of complications
Up to 5 years
Change in quality of life measure
Baseline to up to 3 years
Study Arms (3)
Ovarian Cancer Screening
EXPERIMENTALWoman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound.
Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO)
EXPERIMENTALWoman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure.
Risk-Reducing Salpingo-Oophorectomy (RRSO)
EXPERIMENTALWoman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure.
Interventions
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound.
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure.
Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure.
Ovarian Screening Group: Quality of life (QOL) questionnaire completed at baseline, end of year 1, 2, and 3. Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO): Quality of life (QOL) questionnaire completed at baseline, 1 month 1 year, 2 years, and 3 years after salpingectomy. Also before oophorectomy performed, 1 month and 6 months after oophorectomy. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Quality of life (QOL) questionnaire completed at baseline, then 1 month, 6 months, and 1 year after surgery.
Ovarian Cancer Screening Group: Transvaginal ultrasound performed at baseline and every 6 months for 3 years. Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) group: Transvaginal ultrasound performed at baseline, every 6 months for 3 years after salpingectomy, then before oophorectomy. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Transvaginal ultrasound performed at baseline.
Ovarian Cancer Screening Group and Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) Group: Phone call made to patient one time a year after third year follow up. Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Phone call made to patient 1 day after surgery, 1 week after surgery, then yearly.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Postmenopausal women or women \< 30 or \>/= 48 years of age.
- Women without a documented BRCA mutation.
- 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.
- Medical comorbidities making surgery unsafe as determined by the patient's surgeon.
- Prior bilateral salpingectomy. Prior unilateral salpingectomy is allowed.
- 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.
- 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.
- Inability to provide informed consent.
- Inability to read or speak English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NorthShore University Health System
Evanston, Illinois, 60201, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Nebgen, MD, PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2013
First Posted
July 25, 2013
Study Start
August 26, 2013
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
April 16, 2026
Record last verified: 2026-04