Prevention of Ovarian Cancer in Women Participating in Mammography

Fred Hutchinson Cancer Center1 site in 1 country458 target enrollmentJuly 2008

ConditionsEpithelial Ovarian Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Epithelial Ovarian Cancer
Sponsor: Fred Hutchinson Cancer Center
Enrollment: 458
Locations: 1
Primary Endpoint: Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to evaluate the effect of systematic identification and genetic counseling referral on rates of bilateral salpingo-oophorectomy (surgery to remove both fallopian tubes and ovaries) in women having mammograms at Swedish Medical Center in Seattle, WA.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

December 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Fred Hutchinson Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Prior mammogram at Swedish Medical Center
•Willing and able to provide informed consent, primary physician information, and complete study questionnaires
•Must meet at least ONE of the following criteria:
•personal history of breast cancer diagnosed before age 50
•personal history of bilateral breast cancer at any age
•1 or more first degree relatives with breast cancer diagnosed before age 50
•3 or more first or second degree relatives with breast cancer at any age
•2 second degree relatives with breast cancer diagnosed before age 50
•A male relative with breast cancer at any age
•Ashkenazi Jewish with any family history of breast or ovarian cancer

Exclusion Criteria

•Previous diagnosis of ovarian cancer
•Prior bilateral-salpingo oophorectomy
•Had a negative genetic test result for a known family genetic mutation

Outcomes

Primary Outcomes

Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms

Time Frame: 24 months post-enrollment

Secondary Outcomes

Cancer related distress(change from baseline at 12 and 24 months post-enrollment)
Health-related quality of life(change from baseline at 12 and 24 months post-enrollment)