NCT02760849

Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

WISP (Women Choosing Surgical Prevention)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 30 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives: 1\. To examine changes in female sexual function with the strategy of interval salpingectomy and delayed oophorectomy (ISDO) compared to the strategy of risk-reducing salpingo-oophorectomy (RRSO) for patients who carry genetic mutations that predispose them to ovarian cancer. Secondary Objectives: 1. To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO. 2. To estimate quality of life with ISDO compared to RRSO. 3. To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures. 4. To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality. 5. To determine the compliance with delayed oophorectomy within the ISDO arm. 6. To estimate the number of fallopian tube, ovarian, primary peritoneal malignancies and other malignancies over the course of the study. 7. To identify common themes regarding influential factors in the decision to undergo risk reducing surgery in premenopausal women at genetic high-risk for ovarian can OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients undergo ISDO. ARM II: Patients undergo RRSO. After completion of study treatment, patients are followed up at 1 and 6 months, 1 year, and 2 years.

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

Type	Name	Description
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

Timeline

• Start date: 2016-05-02
• Primary completion: 2041-05-31
• Completion: 2041-05-31
• First posted: 2016-05-04
• Last updated: 2026-01-07

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study