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

NCT03380819 | Completed

• 1 other identifier: 2993
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rare Diseases; Genetic Disease

Outcome Measures

Primary Outcomes (1)

• Primary molecular diagnosis

  Identification of a genetic variant that explains the patient's indication for sequencing

  Baseline

Secondary Outcomes (1)

• Secondary genomic results

  Baseline

Other Outcomes (2)

• Change in clinical management

  3 months

• Self-reported health and quality of life

  3 months

Study Arms (1)

Genome sequencing

EXPERIMENTAL

Patients undergo exome or whole-genome sequencing, and their patients receive an interpreted clinical report.

Diagnostic Test: Genome sequencing

Interventions

Genome sequencing DIAGNOSTIC_TEST

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.

Genome sequencing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient referred by provider to study for genome sequencing
• Life expectancy of at least 12 months in the judgment of the referring provider

You may not qualify if:

• Life expectancy of \<12 months
• Inability to give informed consent

Sponsors & Collaborators

• VA Boston Healthcare System: lead

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Rare Diseases; Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jason L Vassy, MD, MPH, MS

  VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-investigator

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 21, 2017
• Study Start: December 29, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Indefinitely
• Access Criteria: Interested investigators will obtain institutional review board (IRB)-approval and complete a Combined Data Use-Data Transfer Agreement to access the data repository.

Locations

US (1)