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Preventive Surgery for Ovarian Cancer

N/A
Waitlist Available
Led By Karen H Lu
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
Premenopausal women with a documented deleterious mutation in one of the specified ovarian cancer genes
Willing to undergo two surgical procedures (if participant chooses the ISDO arm)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 6 months
Awards & highlights

Study Summary

This trial compares two surgical procedures for preventing ovarian cancer in patients with genetic mutations.

Who is the study for?
This trial is for premenopausal women with certain genetic mutations linked to a high risk of ovarian cancer. Participants must be willing to undergo surgery and follow-up care, not currently pregnant or within 3 months post-partum, have at least one fallopian tube and ovary, and cannot be on specific cancer medications.Check my eligibility
What is being tested?
The study compares two surgeries: Risk Reducing Salpingo-Oophorectomy (RRSO), which removes ovaries and fallopian tubes together; versus Interval Salpingectomy with Delayed Oophorectomy (ISDO), removing only the fallopian tubes first. It aims to find out which method better reduces cancer risk while preserving sexual function and well-being.See study design
What are the potential side effects?
Surgical side effects may include pain, infection, bleeding, scarring, hormonal changes due to removal of reproductive organs affecting sexual function and mood swings. Long-term risks involve early menopause symptoms if ovaries are removed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a premenopausal woman with a genetic mutation linked to ovarian cancer.
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I am willing to have two surgeries if I choose the ISDO treatment option.
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I have had my tubes tied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of women with clinically meaningful change in the Female Sexual Function Index (FSFI) score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (ISDO)Experimental Treatment4 Interventions
Patients undergo ISDO.
Group II: Arm II (RRSO)Active Control3 Interventions
Patients undergo RRSO.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Salpingectomy
2011
Completed Phase 2
~670

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,407 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,779 Total Patients Enrolled
Karen H LuPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
5,200 Total Patients Enrolled

Media Library

Surgery Clinical Trial Eligibility Overview. Trial Name: NCT02760849 — N/A
Breast and Ovarian Cancer Syndrome Research Study Groups: Arm I (ISDO), Arm II (RRSO)
Breast and Ovarian Cancer Syndrome Clinical Trial 2023: Surgery Highlights & Side Effects. Trial Name: NCT02760849 — N/A
Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT02760849 — N/A

Frequently Asked Questions

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

To whom is eligibility for this clinical study extended?

"Applicants to this medical trial should have inherited breast and ovarian cancer syndrome, with ages ranging from 30-50. This clinical study is currently looking for a total of 374 participants."

Answered by AI

Are there several venues across America that are currently undertaking this trial?

"This clinical trial is taking place in 12 separate sites, including Memorial Sloan Kettering Cancer Center (New york), Mayo Clinic (Rochester, Minnesota), and the University of Chicago Comprehensive Cancer Center (Chicago)."

Answered by AI

Are researchers currently recruiting participants for this trial?

"Clinicaltrials.gov reveals that this investigation, initially published on May 2nd 2016 and recently revised on February 25th 2022, is no longer accepting new participants. Nevertheless, there are 547 other clinical trials currently recruiting volunteers."

Answered by AI

Is this research accepting participants who exceed 30 years of age?

"Individuals aged 30-50 years old are eligible to be recruited for this clinical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations
2016. "Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02760849.
~249 spots leftby May 2041
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