Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

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.

Conditions

• Deleterious BARD1 Gene Mutation
• Deleterious BRCA1 Gene Mutation
• Deleterious BRCA2 Gene Mutation
• Deleterious BRIP1 Gene Mutation
• Deleterious EPCAM Gene Mutation
• Deleterious MLH1 Gene Mutation
• Deleterious MSH2 Gene Mutation
• Deleterious MSH6 Gene Mutation
• Deleterious PALB2 Gene Mutation
• Deleterious PMS2 Gene Mutation
• Deleterious RAD51C Gene Mutation
• Deleterious RAD51D Gene Mutation
• Hereditary Breast and Ovarian Cancer Syndrome
• Premenopausal

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Oophorectomy

Undergo ISDO

OTHER

Quality-of-Life Assessment

Ancillary studies

PROCEDURE

Salpingectomy

Undergo ISDO

PROCEDURE

Salpingo-Oophorectomy

Undergo RRSO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Roni N Wilke, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-02

Primary Completion

2041-05-31

Completion

2041-05-31

FDA Drug

Yes

Countries

• United States

Study Locations