Spots Global Cancer Trial Database for Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

Study Description

Brief 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: I. 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: I. To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO. II. To estimate quality of life with ISDO compared to RRSO. III. To examine participants' satisfaction level and cancer worry level with their choice of prophylactic procedures. IV. To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality. V. To determine the compliance with ISDO compared to RRSO. VI. To estimate the number of fallopian tube, ovarian, or primary peritoneal malignancies and other malignancies over the course of the study. 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.

Keywords

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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