Personal Genomics: A Safety Study Assessing the Effects of Receiving Genome Sequencing Results
Observational
Observational Model: Family-Based, Time Perspective: Prospective
Psychological distress
of receiving incidentally identified disease risk results from whole genome/exome sequencing. Safety is defined as no more than 20% of participants experiencing clinically meaningful levels of distress at 1 week follow-up, as measured by the Hospital Anxiety & Depression Scale (HADS; score > or = to 8 on the anxiety sub-scale). Patients will be considered evaluable for the primary outcome if they are not distressed at baseline and have completed the 1 week follow-up assessment.
2 years
Yes
Mark Robson, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
12-167
NCT01692223
September 2012
September 2014
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |