Prevention of Ovarian Cancer in Women Participating in Mammography

January 27, 2016 updated by: Fred Hutchinson Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

458

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Genetic counseling
After randomization the participant is offered a referral to a genetic counselor.
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:

  1. A review of medical and family history information to determine which genetic test (BRCA, HNPCC, p53, etc.), if any, is appropriate;
  2. Discuss how the results - positive or negative - affect cancer risk
  3. Discuss how cancer risk might be managed (surveillance, prophylactic surgery, oral contraceptives, etc.);
  4. Discuss how the test is conducted and what the results might be (positive, negative, uncertain);
  5. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms
Time Frame: 24 months post-enrollment
24 months post-enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Cancer related distress
Time Frame: change from baseline at 12 and 24 months post-enrollment
change from baseline at 12 and 24 months post-enrollment
Health-related quality of life
Time Frame: change from baseline at 12 and 24 months post-enrollment
change from baseline at 12 and 24 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

Swedish Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R18DP001142-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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