Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Syndrome

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hereditary Breast and Ovarian Cancer Syndrome

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Neoplasms

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Breast Diseases

Skin Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Laboratory Biomarker Analysis

Oophorectomy

Quality-of-Life Assessment

Salpingectomy

Salpingo-Oophorectomy

Karen H Lu

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.

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.

Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations

WISP (Women Choosing Surgical Prevention)

Will be calculated using the Cochran-Mantel-Haenszel test stratified by age, with 5-year age groups. We will use propensity score methods to account for potential differences between interval salpingectomy with delayed oophorectomy (ISDO) and risk-reducing bilateral salpingectomy with oophorectomy (RRSO) arms with respect to age, baseline survey scores, and other potential confounders, and we will use the propensity scores as inverse weights in logistic regression to model the logit of the probability of having a clinically meaningful change in FSFI score from baseline to 6 months as our primary analysis.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations	NCT02760849	Deleterious BAR... Deleterious BRC... Deleterious BRC... Deleterious BRI... Deleterious EPC... Deleterious MLH... Deleterious MSH... Deleterious MSH... Deleterious PAL... Deleterious PMS... Deleterious RAD... Deleterious RAD... Hereditary Brea... Premenopausal	Laboratory Biom... Oophorectomy Quality-of-Life... Salpingectomy Salpingo-Oophor...	30 Years - 50 Years	M.D. Anderson Cancer Center
Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations	NCT02760849	Deleterious BAR... Deleterious BRC... Deleterious BRC... Deleterious BRI... Deleterious EPC... Deleterious MLH... Deleterious MSH... Deleterious MSH... Deleterious PAL... Deleterious PMS... Deleterious RAD... Deleterious RAD... Hereditary Brea... Premenopausal	Laboratory Biom... Oophorectomy Quality-of-Life... Salpingectomy Salpingo-Oophor...	30 Years - 50 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for deleterious mlh1 gene mutation