Prevention of Ovarian Cancer in Women Participating in Mammography

Epithelial Ovarian Cancer Clinical Trial

Official title:

Prevention of Ovarian Cancer in Women Participating in Mammography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851109
• Other study ID #: 1R18DP001142-01
• Status: Completed
• Phase: N/A
• First received: May 3, 2013
• Last updated: January 27, 2016
• Start date: July 2008
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: December 2015
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

• 1 first or second degree relative with ovarian cancer AND 1 first or second degree relative with breast cancer at any age

• 2 first degree relatives with ovarian cancer or 2 second degree relatives with ovarian cancer or 1 first and 1 second degree relative with ovarian cancer.

• A first degree relative with both breast and ovarian cancer (2 primaries in the same person)

• Personal history of positive genetic test result for any of the following genes:

BRCA1, BRCA2, HNPCC, or P53

• Family history of a positive genetic test result for any of the following genes:

BRCA1, BRCA2 or HNPCC

Exclusion Criteria:

• Previous diagnosis of ovarian cancer

• Prior bilateral-salpingo oophorectomy

• Had a negative genetic test result for a known family genetic mutation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Behavioral:
• genetic counseling
The genetic counseling sessions are conducted by a licensed genetic counselor, certified by the American Board of Genetic Counseling and the American Board of Medical Genetics. This clinical counseling session may include, but is not limited to the following: A review of medical and family history information to determine which genetic test (BRCA, HNPCC, p53, etc.), if any, is appropriate; Discuss how the results - positive or negative - affect cancer risk Discuss how cancer risk might be managed (surveillance, prophylactic surgery, oral contraceptives, etc.); Discuss how the test is conducted and what the results might be (positive, negative, uncertain); Discuss the disadvantages of genetic testing (cost, insurance coverage, worry about insurance discrimination, uncertain results, etc.) and the psychological and emotional issues surrounding testing, etc.

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms		24 months post-enrollment	No
Secondary	Cancer related distress		change from baseline at 12 and 24 months post-enrollment	Yes
Secondary	Health-related quality of life		change from baseline at 12 and 24 months post-enrollment	Yes