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Completed

NCT Number: NCT03380819

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Primary molecular diagnosis

    Time frame: Baseline

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

Secondary outcomes

  1. Secondary genomic results

    Time frame: Baseline

    Pathogenic or likely pathogenic variants in over 4600 genes associated with monogenic disease risk, carrier status variants, and pharmacogenomic results

Other outcomes

  1. Change in clinical management

    Time frame: 3 months

    Evidence that genome sequencing results changed the medical care of the patient

  2. Self-reported health and quality of life

    Time frame: 3 months

    Veterans Rand (VR)-12

Sponsors and collaborators

Lead sponsor

VA Boston Healthcare System

Fed

Registry information

Official study title

Clinical Safety and Efficacy of Pharmacogenetics in Veteran Care

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2017
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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