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

Conditions

• Ovarian Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

35 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Bilateral Salpingectomy — PROCEDURE
  Undergo bilateral salpingectomy
• Bilateral Salpingectomy with Oophorectomy — PROCEDURE
  Undergo bilateral salpingo-oophorectomy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Magnetic Resonance Imaging — PROCEDURE
  Undergo pelvic MRI
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Transvaginal Ultrasound — PROCEDURE
  Undergo transvaginal ultrasound
• Ultrasound Imaging — PROCEDURE
  Undergo pelvic ultrasound

Study Details

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.

Key Dates

Start date

Sep 1, 2020

Status verified

Mar 2026

Primary completion

Jun 30, 2047

Completion

Jun 30, 2047

Study Design

Enrollment

1,956 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group I (bilateral salpingectomy)
  Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.
• Active Comparator: Group II (bilateral salpingo-oophorectomy)
  Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound or pelvic MRI during screening and blood sample collection throughout the trial.

Primary Outcome Measure

Time to development of incident high-grade serous carcinomas (HGSC), specifically ovarian, primary peritoneal, or fallopian tube cancers [ Time Frame: Up to 20 years ]

Locations (539)

Find similar trials in Birmingham, AL

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