Multiplex Testing for Breast Cancer Susceptibility: A Pilot Study of Subject Preferences for Information and Responses After Testing

Memorial Sloan Kettering Cancer Center1 site in 1 country197 target enrollmentNovember 2013

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 197
Locations: 1
Primary Endpoint: women's preferences with respect to the type of information they would like to receive from multiplex testing
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

December 1, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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
•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.

Exclusion Criteria

•Unable to provide informed consent for testing
•Unable to complete English language questionnaire

Outcomes

Primary Outcomes

women's preferences with respect to the type of information they would like to receive from multiplex testing

Time Frame: 2 years

Proportions of subjects declaring a pre-test preference to receive 1) all available information, 2) all information related to breast cancer predisposition (whether or not clinical utility is established), 3) all information of established clinical utility (whether related to breast cancer risk or not), 4) only a subset of high-penetrance information (masking certain results), 5) no information.