Multiplex Testing for Breast Cancer Susceptibility: A Pilot Study of Subject Preferences for Information and Responses After Testing
This trial is active, not recruiting.
|Treatments||pre-test assessment, pre test counseling, blood draw, post-test counseling, and post-test assessment, follow-up assessments (6 and 12 months)|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||November 2013|
|End date||November 2016|
|Trial size||197 participants|
|Trial identifier||NCT01992471, 13-215|
The purpose of this study is to find out what kinds of information people would like to receive from a new kind of genetic testing, and how they respond to this new kind of testing.
women's preferences with respect to the type of information they would like to receive from multiplex testing
time frame: 2 years
Male or female participants at least 18 years old.
Inclusion Criteria: - Male or Female age 18 or older - Personal history of breast cancer AND one of the following: - Invasive breast cancer or DCIS diagnosed at or before age 45 Invasive breast cancer diagnosed at/before age 50 with one or more of the following: - Limited family history (Fewer than 2 first- or second-degree female relatives in the same lineage that lived to age 45. The "limited family history" can occur on either the maternal or paternal side of the family.) - 1 or more first-/second-degree relatives with invasive BC at/before 50 - 1 or more first-/second-degree relatives with invasive epithelial ovarian cancer (any age) - 1 or more first- or second-degree relatives with male breast cancer - 2 or more first- or second-degree relatives with pancreas cancer - Invasive breast cancer diagnosed at or before age 60 with at least 2 first or second-degree relatives affected with any combination of invasive breast cancer before age 50, invasive epithelial ovarian cancer at any age, male breast cancer, or pancreas cancer. - Full sequence BRCA1 and BRCA2 testing completed with no deleterious mutation identified. Exclusion Criteria: - Unable to provide informed consent for testing - Unable to complete English language questionnaire
|Official title||Multiplex Testing for Breast Cancer Susceptibility: A Pilot Study of Subject Preferences for Information and Responses After Testing|
|Principal investigator||Mark Robson, MD|
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