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Trial record 67 of 9181 for:    Genetic Diseases, Inborn AND genetic disorder

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

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ClinicalTrials.gov Identifier: NCT03380819
Recruitment Status : Enrolling by invitation
First Posted : December 21, 2017
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jason L. Vassy, MD, MPH, SM, VA Boston Healthcare System

Tracking Information
First Submitted Date  ICMJE December 15, 2017
First Posted Date  ICMJE December 21, 2017
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE December 29, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
Primary molecular diagnosis [ Time Frame: Baseline ]
Identification of a genetic variant that explains the patient's indication for sequencing
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03380819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 15, 2017)
  • Change in clinical management [ Time Frame: 3 months ]
    Evidence that genome sequencing results changed the medical care of the patient
  • Self-reported health and quality of life [ Time Frame: 3 months ]
    Veterans Rand (VR)-12
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The VetSeq Study: a Pilot Study of Genome Sequencing in Veteran Care
Official Title  ICMJE Clinical Safety and Efficacy of Pharmacogenetics in Veteran Care
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Rare Diseases
  • Genetic Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Genome sequencing
Patients undergo exome or whole-genome sequencing, and their patients receive an interpreted clinical report.
Intervention: Diagnostic Test: Genome sequencing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: December 15, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03380819
Other Study ID Numbers  ICMJE 2993
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: A research data repository will be created from the genome sequence data, genome report data, patient survey data, and data abstracted from medical charts. identified genome sequence data.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (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.
Responsible Party Jason L. Vassy, MD, MPH, SM, VA Boston Healthcare System
Study Sponsor  ICMJE VA Boston Healthcare System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason L Vassy, MD, MPH, SM VA Boston Healthcare System
PRS Account VA Boston Healthcare System
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP