RECRUITING
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The Genomic Medicine at VA Study
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:
🦠 Coronary Artery Disease 🦠 Atrial Fibrillation 🦠 Type 2 Diabetes 🦠 Colorectal Cancer 🦠 Breast Cancer 🦠 Prostate Cancer
🗓️ Study Start (Actual) 17 July 2020
🗓️ Primary Completion (Estimated) 30 September 2025
✅ Study Completion (Estimated) 30 September 2025
👥 Enrollment (Estimated) 1076
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age 50-70 years at enrollment
    • * No known diagnosis of the following conditions, initially screened by the International Classification of Disease (ICD) codes or other electronic health record (EHR) data using validated methods and then confirmed with potential patient-participants during recruitment: coronary artery disease, atrial fibrillation, type 2 diabetes, colorectal cancer, breast cancer, prostate cancer

    Exclusion Criteria:

    • * Patients will be ineligible if they:
    • * Have a known diagnosis of at least one of the six diseases of interest
    • * Are younger than age 50 or older than age 70
    • * Are pregnant
    • * Are incarcerated or institutionalized
Ages Eligible for Study: 50 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 March 2020
  • First Submitted that Met QC Criteria 31 March 2020
  • First Posted 2 April 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 September 2022
  • Last Update Posted 3 October 2022
  • Last Verified September 2022
I'm interested ...!!