RECRUITING

The Genomic Medicine at VA Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pragmatic Randomized Trial of Polygenic Risk Scoring for Common Diseases in Primary Care

Quick Facts

Study Start:2020-07-17
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04331535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 50-70 years at enrollment
  2. * 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
  1. * Patients will be ineligible if they:
  2. * Have a known diagnosis of at least one of the six diseases of interest
  3. * Are younger than age 50 or older than age 70
  4. * Are pregnant
  5. * Are incarcerated or institutionalized

Contacts and Locations

Study Contact

Jason L. Vassy, MD, MPH, SM
CONTACT
857-364-2561
jvassy@partners.org

Principal Investigator

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

Study Locations (Sites)

VA Boston Healthcare System
Boston, Massachusetts, 02130-4817
United States

Collaborators and Investigators

Sponsor: Boston VA Research Institute, Inc.

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

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

Study Start Date2020-07-17
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2020-07-17
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • Polygenic risk score
  • Coronary artery disease
  • Atrial fibrillation
  • Type 2 diabetes
  • Colorectal cancer
  • Breast cancer
  • Prostate cancer

Additional Relevant MeSH Terms

  • Coronary Artery Disease
  • Atrial Fibrillation
  • Type 2 Diabetes
  • Colorectal Cancer
  • Breast Cancer
  • Prostate Cancer