Prophylactic Salpingectomy With Delayed Oophorectomy (NCT01907789) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prophylactic Salpingectomy With Delayed Oophorectomy
United States80 participantsStarted 2013-08-26
Plain-language 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.
Who can participate
Age range
30 Years – 47 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying whether women will actually follow through with both the tube removal first and then the ovary removal later — how does that two-step approach compare to removing everything at once, and which option might make more sense for my situation?
2Since this study is in a 'NA' phase and focused on patient compliance rather than measuring cancer outcomes directly, what do we actually know so far about whether removing the tubes first and delaying ovary removal truly lowers ovarian cancer risk compared to standard risk-reducing surgery?
3The trial is no longer enrolling new patients — does that mean results are expected soon, and how might those findings change the recommendation you'd make to me about preventive surgery?
4If I'm at high risk for ovarian cancer, should I consider waiting to see what this study concludes about the delayed oophorectomy strategy, or is there a reason I shouldn't delay a decision about my own surgery right now?
5What are the known risks of keeping the ovaries in place during the waiting period between the two surgeries, and how would my personal risk factors — like my age or whether I carry a BRCA mutation — affect whether that delay is safe for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Compliance with Prophylactic Salpingectomy with Delayed Oophorectomy Strategy
. 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.
Exclusion criteria
. 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.