MedTrace Logo

A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer

NCT04251052 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1956

Last updated 2026-03-27

No results posted yet for this study

Summary

This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.

Conditions

  • Ovarian Carcinoma

Interventions

PROCEDURE

Bilateral Salpingectomy

Undergo bilateral salpingectomy

PROCEDURE

Bilateral Salpingectomy with Oophorectomy

Undergo bilateral salpingo-oophorectomy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Magnetic Resonance Imaging

Undergo pelvic MRI

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Transvaginal Ultrasound

Undergo transvaginal ultrasound

PROCEDURE

Ultrasound Imaging

Undergo pelvic ultrasound

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Principal Investigators

  • Kathryn P Pennington · NRG Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2047-06-30
Completion
2047-06-30

Countries

  • United States
  • Canada
  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04251052 on ClinicalTrials.gov