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The Genomic Medicine at VA Study

NCT04331535 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1076

Last updated 2022-10-03

No results posted yet for this study

Summary

This trial will determine the clinical effectiveness of polygenic risk score testing among patients at high genetic risk for at least one of six diseases (coronary artery disease, atrial fibrillation, type 2 diabetes mellitus, colorectal cancer, breast cancer, or prostate cancer), measured by time-to-diagnosis of prevalent or incident disease over 24 months.

Conditions

Interventions

DIAGNOSTIC_TEST

Polygenic risk score (PRS)

Polygenic risk score report from a Clinical Laboratory Improvement Amendment (CLIA)-certified laboratory for coronary artery disease, atrial fibrillation, type 2 diabetes, colorectal cancer, breast cancer (for women only), and prostate cancer (for men only), delivered along with patient- and provider-level educational material.

Sponsors & Collaborators

  • VA Boston Healthcare System

    collaborator FED

  • Boston VA Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Jason L. Vassy, MD, MPH, SM · Harvard Medical School (HMS and HSDM)

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331535 on ClinicalTrials.gov