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

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Pre-test Assessment; Behavioral: Pre test Counseling; Other: Blood draw; Behavioral: Post-test counseling, and post-test assessment; Behavioral: Follow-up assessments (6 and 12 months)

• Registration Number: NCT01992471
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Status Verified: 2017-12
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
history of breast cancer who have undergone BRCA1/2 testing	Blood draw	This is a single-arm observational study. Subjects with a history of breast cancer who have undergone BRCA1/2 testing and have received uninformative findings will enroll in this study, and then receive pre-test counseling for multiplex testing.
history of breast cancer who have undergone BRCA1/2 testing	Pre-test Assessment	This is a single-arm observational study. Subjects with a history of breast cancer who have undergone BRCA1/2 testing and have received uninformative findings will enroll in this study, and then receive pre-test counseling for multiplex testing.
history of breast cancer who have undergone BRCA1/2 testing	Follow-up assessments (6 and 12 months)	This is a single-arm observational study. Subjects with a history of breast cancer who have undergone BRCA1/2 testing and have received uninformative findings will enroll in this study, and then receive pre-test counseling for multiplex testing.
history of breast cancer who have undergone BRCA1/2 testing	Pre test Counseling	This is a single-arm observational study. Subjects with a history of breast cancer who have undergone BRCA1/2 testing and have received uninformative findings will enroll in this study, and then receive pre-test counseling for multiplex testing.
history of breast cancer who have undergone BRCA1/2 testing	Post-test counseling, and post-test assessment	This is a single-arm observational study. Subjects with a history of breast cancer who have undergone BRCA1/2 testing and have received uninformative findings will enroll in this study, and then receive pre-test counseling for multiplex testing.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States