NCT03380819

The VetSeq Study: a Pilot Study of Genome Sequencing in Veteran Care

Clinical Safety and Efficacy of Pharmacogenetics in Veteran Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: VA Boston Healthcare System · Federal
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The VetSeq Study is a pilot intervention study exploring the feasibility of integrating genome sequencing into clinical care at the VA Boston Healthcare System.

Detailed description

The VetSeq Study is a pilot intervention study exploring the feasibility of integrating genome sequencing into clinical care at the VA Boston Healthcare System. Healthcare providers may refer any patients who they think might benefit from diagnostic whole genome or exome sequencing. Providers will briefly discuss genome sequencing and the pilot study with potentially eligible patients. If a patient is interested, the provider will refer him/her to the study by contacting the study staff and providing the reason (clinical question) why the provider thinks genome sequencing might be beneficial for the patient. The study staff will meet with the patient to conduct a baseline interview and survey, obtain informed consent for sequencing, and obtain a blood specimen for sequencing. A clinical laboratory will perform exome or whole-genome sequencing and issue an interpreted genome report including any variant possibly explaining the patient's condition, in addition to secondary monogenic, carrier, and pharmacogenomic results. This report will be sent to the referring provider, who will document the results and associated decision-making in the medical record. Approximately 3 months later, study staff will conduct a follow-up interview and survey with the participating patient.

Conditions

• Rare Diseases
• Genetic Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Genome sequencing	Patients will undergo exome or genome sequencing, and their referring provider will receive an interpreted report with the following categories of results: 1) results related to the indication for testing, 2) secondary monogenic results, 3) carrier status, 4) pharmacogenomics results.

Timeline

• Start date: 2017-12-29
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2017-12-21
• Last updated: 2023-04-26

Locations

1 site across 1 country: United States