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Risk-Reducing Surgery for Ovarian Cancer

N/A

Recruiting

Led By Roni Wilke, MD

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

Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D

Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C and/or RAD51D gene germline mutation

Must not have

Current clinical signs, diagnosis or treatment for malignant disease

A personal history of ovarian, fallopian tube or peritoneal cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two treatments for ovarian cancer to see if one is better than the other.

Who is the study for?

This trial is for premenopausal women aged 25-50 with specific genetic mutations (BRCA1, BRCA2, BRIP1, RAD51C/D) who have completed childbearing and have at least one fallopian tube. It's not for those with a history of ovarian cancers or currently in cancer treatment.

What is being tested?

The study compares two preventive surgeries for high-risk women: immediate removal of fallopian tubes and ovaries (RRSO) versus just the tubes first then ovaries later (RRS with delayed RRO). The goal is to see if delaying ovary removal affects cancer incidence.

What are the potential side effects?

Potential side effects may include surgical risks like bleeding or infection, early menopause symptoms due to ovary removal, psychological impacts from altered body image or loss of fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am within the age range specified for my specific genetic mutation.

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I am a premenopausal woman with a harmful gene mutation linked to cancer.

Exclusion Criteria

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

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I am currently being treated for cancer.

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

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I have had both of my fallopian tubes surgically removed.

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I am not legally able to make my own decisions.

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I am postmenopausal naturally or due to cancer treatment.

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I plan to have a second surgery within two years after my first risk-reducing surgery.

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

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-RRSOExperimental Treatment1 Intervention

Can help to lower the risk of ovarian cancer as well as the standard-of-care risk-reducing procedure involving the removal of the fallopian tubes and ovaries (risk-reducing salpingo-oophorectomy-RRSO)

Group II: Risk-Reducing Salpingectomy-RRSExperimental Treatment1 Intervention

Can help to lower the risk of ovarian cancer with a delayed removal of 1.

Group III: Risk-Reducing Oophorectomy-RROExperimental Treatment1 Intervention

Can help to lower the risk of ovarian cancer removing both fallopian tubes.

0 / 8Eligibility criteria met