← Back to Search

Risk-Reducing Surgery for Ovarian Cancer

N/A
Recruiting
Led By Karen Lu, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am within the age range specified for my specific genetic mutation.
Select...
I am a premenopausal woman with a harmful gene mutation linked to cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.

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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,264 Total Patients Enrolled
46 Trials studying Ovarian Cancer
16,645 Patients Enrolled for Ovarian Cancer
Karen Lu, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Ovarian Cancer Research Study Groups: Risk-Reducing Oophorectomy-RRO, Risk-Reducing Salpingo-Oophorectomy-RRSO, Risk-Reducing Salpingectomy-RRS
Ovarian Cancer Clinical Trial 2023: Risk-Reducing Oophorectomy-RRO Highlights & Side Effects. Trial Name: NCT05287451 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are eligible to participate in the experiment?

"Indeed, the evidence listed on clinicaltrials.gov points to an active recruitment period for this medical experiment. It was opened on May 10th 2022 and most recently updated on that same date. The trial requires 100 patients from a single site."

Answered by AI

Is it still possible to join this clinical research program?

"Affirmative. As per the clinicaltrials.gov platform, this medical trial is still looking for patients to participate in the study since it was first posted on May 10th 2022 and recently updated on that same date. The research team needs 100 participants from one site only."

Answered by AI
~58 spots leftby Dec 2026