Prophylactic Salpingectomy With Delayed Oophorectomy

NAActive, not recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 26, 2013

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2030

Conditions
Ovarian Carcinoma
Interventions
OTHER

Ovarian Cancer Screening

Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound.

PROCEDURE

Prophylactic Salpingectomy with Delayed Oophorectomy

Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure.

PROCEDURE

Risk-Reducing Salpingo-Oophorectomy

Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure.

BEHAVIORAL

Questionnaire

"Ovarian Screening Group: Quality of life (QOL) questionnaire completed at baseline, end of year 1, 2, and 3.~Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO): Quality of life (QOL) questionnaire completed at baseline, 1 month 1 year, 2 years, and 3 years after salpingectomy. Also before oophorectomy performed, 1 month and 6 months after oophorectomy.~Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Quality of life (QOL) questionnaire completed at baseline, then 1 month, 6 months, and 1 year after surgery."

PROCEDURE

Transvaginal Ultrasound

"Ovarian Cancer Screening Group: Transvaginal ultrasound performed at baseline and every 6 months for 3 years.~Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) group: Transvaginal ultrasound performed at baseline, every 6 months for 3 years after salpingectomy, then before oophorectomy.~Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Transvaginal ultrasound performed at baseline."

BEHAVIORAL

Phone Call

"Ovarian Cancer Screening Group and Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) Group: Phone call made to patient one time a year after third year follow up.~Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Phone call made to patient 1 day after surgery, 1 week after surgery, then yearly."

Trial Locations (2)

60201

NorthShore University Health System, Evanston

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT01907789 - Prophylactic Salpingectomy With Delayed Oophorectomy | Biotech Hunter | Biotech Hunter