Status:
COMPLETED
Evaluation of a Decision Aid for Incidental Genomic Findings
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Health care providers (HCP) are increasingly using genomic sequencing (GS) to target treatment for patients. However, GS may incidentally reveal inherited risks for thousands of current and future dis...
Detailed Description
BACKGROUND: Health care providers are increasingly using GS to diagnose, prognose and treat diseases. GS offers increased sensitivity over classic genetic tests, decreasing time-consuming and costly d...
Eligibility Criteria
Inclusion
- Patients with a family history of cancer
- Received a negative single gene test for a cancer gene mutation (e.g., BRCA1/2, MLH, MSH, PMS, etc.) or received a negative panel test
- Speak and read English
Exclusion
- Are in advanced stage cancer (stage 5)
- Received positive panel testing or panel sequencing
- Have not had single gene testing related to their primary cancer condition (e.g., BRCA1/2 for breast/ovarian cancer, MLH, MSH, PMS colorectal cancer, etc.)
- Received a positive genetic test for a cancer gene mutation (e.g., BRCA1/2, MLH, MSH, PMS, APC, MUTYH, etc.)
- Do not speak or read English
- Family member participating in the study
- Participant in usability study of the DA
Key Trial Info
Start Date :
September 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2018
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT03244202
Start Date
September 12 2016
End Date
April 2 2018
Last Update
April 17 2018
Active Locations (2)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada
2
Sunnybrook Hospital
Toronto, Ontario, Canada