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Salpingectomy with Delayed Oophorectomy for Ovarian Cancer

N/A
Waitlist Available
Led By Denise Nebgen, MD, PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will compare ovarian cancer screening, RRSO, and PSDO to see which is most effective in reducing risk.

Who is the study for?
This trial is for premenopausal women aged 30-47 with a BRCA1 or BRCA2 mutation, who are candidates for surgery and desire permanent sterilization. They must be willing to undergo two surgeries if choosing the PSDO arm and have completed any cancer treatments at least 3 months prior.Check my eligibility
What is being tested?
The study compares ovarian cancer screening methods with two surgical procedures: risk-reducing salpingo-oophorectomy (RRSO) where both fallopian tubes and ovaries are removed, and prophylactic salpingectomy with delayed oophorectomy (PSDO), which removes fallopian tubes first, delaying ovary removal.See study design
What are the potential side effects?
Potential side effects include those associated with surgical procedures such as pain, infection, bleeding, or reactions to anesthesia. Long-term effects may involve hormonal changes due to ovary removal in RRSO or later in PSDO.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman between 30 and 48 years old.
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I am willing and able to have two surgeries if I choose the PSDO option.
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I am willing to go back to the hospital where I enrolled for all needed surgeries and follow-up care.
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I am a premenopausal woman with a BRCA1 or BRCA2 mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient Compliance with Prophylactic Salpingectomy with Delayed Oophorectomy Strategy
Secondary outcome measures
Change in quality of life measure
Number of complications
Number of occult malignancies
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Risk-Reducing Salpingo-Oophorectomy (RRSO)Experimental Treatment4 Interventions
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.
Group II: Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO)Experimental Treatment4 Interventions
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.
Group III: Ovarian Cancer ScreeningExperimental Treatment4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transvaginal Ultrasound
2021
Completed Phase 4
~1000
Questionnaire
2014
Completed Phase 2
~20090
Phone Call
2016
Completed Phase 4
~20190

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,722 Total Patients Enrolled
47 Trials studying Ovarian Cancer
16,745 Patients Enrolled for Ovarian Cancer
Denise Nebgen, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Prophylactic Salpingectomy With Delayed Oophorectomy
2013. "Prophylactic Salpingectomy With Delayed Oophorectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01907789.
~31 spots leftby Dec 2030
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