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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).

Must not have

Postmenopausal women or women < 30 or >/= 48 years of age.

Women without a documented BRCA mutation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman who is either postmenopausal, under 30, or 48 years old or older.

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I do not have a BRCA gene mutation.

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I have had ovarian, fallopian tube, or primary peritoneal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Compliance with Prophylactic Salpingectomy with Delayed Oophorectomy Strategy

Secondary study objectives

Change in quality of life measure

Number of complications

Number of occult malignancies

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~19970