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NCT02760849 · ClinicalTrials.gov registry record · NA

Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

A NA study of Deleterious BRCA1 Gene Mutation and Deleterious BRCA2 Gene Mutation, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
NA
Development phase
374
Enrollment target
9
Study locations

NCT02760849: Active NA study of Deleterious BRCA1 Gene Mutation and Deleterious BRCA2 Gene Mutation, sponsored by M.D. Anderson Cancer Center.

NCT02760849 is a NA study of Deleterious BRCA1 Gene Mutation and Deleterious BRCA2 Gene Mutation that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 374 participants, above the 39-participant average among 3 other Deleterious BRCA1 Gene Mutation trials with a reported enrollment target (859% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02760849, a NA study of Deleterious BRCA1 Gene Mutation and Deleterious BRCA2 Gene Mutation, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
374 participants
Enrollment target
9
Study locations

Study Summary

This phase II trial studies how well surgery works in preventing ovarian cancer in patients with genetic mutations at risk of ovarian cancer. Risk reducing salpingo oophorectomy (RRSO) is surgery to remove the fallopian tubes and ovaries at the same time. Interval salpingectomy with delayed oophorectomy (ISDO) is surgery to remove the fallopian tubes. It is not known whether ISDO works better than RRSO at lowering risk of ovarian cancer and improving the sexual function and psychosocial well-being in patients with genetic mutation.

Primary Outcome

Will be calculated using the Cochran-Mantel-Haenszel test stratified by age, with 5-year age groups. We will use propensity score methods to account for potential differences between interval salpingectomy with delayed oophorectomy (ISDO) and risk-reducing bilateral salpingectomy with oophorectomy (RRSO) arms with respect to age, baseline survey scores, and other potential confounders, and we will use the propensity scores as inverse weights in logistic regression to model the logit of the proba

Conditions Studied

Deleterious BRCA1 Gene Mutation Deleterious BRCA2 Gene Mutation Deleterious PALB2 Gene Mutation Deleterious BARD1 Gene Mutation Deleterious BRIP1 Gene Mutation Deleterious EPCAM Gene Mutation Deleterious MLH1 Gene Mutation Deleterious MSH2 Gene Mutation Deleterious MSH6 Gene Mutation Deleterious PMS2 Gene Mutation

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Laboratory Biomarker Analysis
  • PROCEDURE Salpingectomy
  • PROCEDURE Oophorectomy
  • PROCEDURE Salpingo-Oophorectomy

Study Locations (9)

New York

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
  • Memorial Sloan Kettering Cancer Center - New York

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Minnesota

  • Mayo Clinic - Rochester

Missouri

  • Siteman Cancer Center at Washington University - St Louis

Pennsylvania

  • University of Pennsylvania/Abramson Cancer Center - Philadelphia

Texas

  • M D Anderson Cancer Center - Houston

Washington

  • University of Washington Medical Center - Seattle

Trial Details

FieldValue
Enrollment Target 374 participants
Start Date 2016-05-02
Est. Completion 2041-05-31
Phase NA
M.D. Anderson Cancer Center

2,692 total trials

What the registry record for NCT02760849 still lists

NCT02760849 is an interventional study that assigns participants to a tested intervention. The registered 374 participants enrollment target is mid-sized for trials with a published cap, above the 39-participant average among 3 other Deleterious BRCA1 Gene Mutation trials with a reported enrollment target (859% higher).

The record links to 10 conditions, with Deleterious BRCA1 Gene Mutation appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.

NCT02760849 lists 9 locations in 8 states (New York, Illinois, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT02760849 about?

NCT02760849 is a clinical study titled "Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations". This phase II trial studies how well surgery works in preventing ovarian cancer in patients with genetic mutations at risk of ovarian cancer. Risk reducing salpingo oophorectomy (RRSO) is surgery to remove the fallopian tubes and ovaries at the same time. Interval salpingectomy with delayed oophorec...

What is the current status of trial NCT02760849?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 374 participants. The study started on 2016-05-02. Estimated completion is 2041-05-31.

What conditions does trial NCT02760849 study?

This clinical trial studies the following conditions: Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Deleterious PALB2 Gene Mutation, Deleterious BARD1 Gene Mutation, Deleterious BRIP1 Gene Mutation.

What interventions are being tested in trial NCT02760849?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Salpingectomy (PROCEDURE), Oophorectomy (PROCEDURE), Salpingo-Oophorectomy (PROCEDURE).

Who is sponsoring clinical trial NCT02760849?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02760849 being conducted?

This trial has 9 study locations across Illinois, Massachusetts, Minnesota, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT02760849, the US trial registry maintained by the National Library of Medicine. NCT02760849 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.