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  • NIH Sep 30, 2001 | R01

    Process & Outcomes of BRCAL/2 clinical testing

    Principal Investigator(s): Garber, Judy

    Institution: Dana-Farber Cancer Institute

    FOA Number: N/A

    Abstract

    The genes conferring increased susceptibility to breast and ovarian cancer, BRCA1 and BRACA2, were identified in the mid-1990's and commercial testing became available soon thereafter. Intensive evaluation of women undergoing testing for BRCA1/2 germline mutations has been conducted, and has demonstrated that women participating in genetic testing through highly structured and supportive programs conducted largely at academic institutions have generally done well through the process and in the long term (1-5). In the United States, the vast majority of BRCA1/2 testing is now performed by a single commercial clinical laboratory {Myraid Genetics Laboratory (MGL}, with the test available to women directly through their physicians. A substantial portion of testing is now accomplished through this mechanism, but the extent to which clinical testing as it is now performed approximates the intensive support provided in the structured research programs is unknown. The outcomes of women tested clinically outside of academic centers have not yet been studied. In this project, we intend to explore three areas in which data have been lacking, using the unique resource of the unselected population of women tested through MGL. These include: 1) What are the outcomes (knowledge, psychological adjustment, health behaviors, satisfaction, and confidentiality concerns) of women undergoing testing across the spectrum of clinical settings in which testing is carried out? 2) Are specific characteristics of providers (experience, expertise, use of genetic counselors) and of the circumstances in which testing is provided (academic, non-academic, specialty vs. course of clinical practice) associated with more favorable outcomes for women undergoing testing? and 3) What are the factors that distinguish physicians who are ordering BRCA1/2 genetic testing from those who have not utilized this new technology? The project involves surveys of women who have provided specimens to MGL for BRCA1/2 analysis, their providers, and control physicians. The information learned from this project may help to create a standard for the optimal conduct of BRCA1/2 testing, and potentially for other predisposition testing as well.

    FUNDING AGENCY:

    Funder:
    NIH

    Institute:
    NATIONAL HUMAN GENOME RESEARCH INSTITUTE

    Funding Type:
    R01

    Project Number:
    R01HG002318

    Start Date:
    Sep 30, 2001

    End Date:
    Aug 31, 2004

    PROJECT TERMS:

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