Clinical trial NCT04331535: The Genomic Medicine at VA Study
Official title: Pragmatic Randomized Trial of Polygenic Risk Scoring for Common Diseases in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Atrial Fibrillation
Type 2 Diabetes
Colorectal Cancer
Breast Cancer
Prostate Cancer
Keywords: Polygenic risk score
Coronary artery disease
Atrial fibrillation
Type 2 diabetes
Colorectal cancer
Breast cancer
Prostate cancer
Lead sponsor: Boston VA Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: VA Boston Healthcare System
First posted: 2020-04-02
Enrollment: 1076
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial comparing polygenic risk score (PRS) testing and reporting to delayed reporting
Primary purpose: SCREENING

Brief 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.

Detailed description: One of the most pressing controversies in genomics today is the clinical utility of polygenic risk scores (PRS). Broadening the scope of genomic risk testing beyond monogenic diseases, PRS combine information from hundreds or even millions of genetic loci, each with a very small effect size on the risk of common complex disease. The result is a continuous quantitative risk factor for susceptibility to conditions such as coronary artery disease (CAD), type 2 diabetes (T2D), and breast cancer. Compared to rarer monogenic disease variants, PRS have greater transformative potential for public health and healthcare in their ability to identify much larger proportions of the population at significantly elevated risk for disease, facilitating evidence-based prevention and management. Moreover, their prediction ability has vastly improved compared to earlier PRS that included only a limited number of genetic variants. However, while the associations between PRS and a wide range of common diseases are well established (clinical validity), the potential impact of this information on patient health outcomes (clinical utility) remains contested and understudied.

This study will examine the effectiveness and implementation outcomes from the use of PRS for 6 common diseases that are screened for by PCPs and have established prevention strategies: CAD, AFib, T2D, colorectal cancer, prostate cancer, and breast cancer. This trial has two aims:

Aim 1: Conduct a randomized controlled trial (RCT) to determine the clinical effectiveness of PRS among patients at high genetic risk for at least one disease, measured by changes in clinical management (process outcomes) and time to diagnosis of prevalent or incident disease (clinical outcome) over 24 months.

Aim 2: Measure high-priority genomic medicine implementation outcomes, including primary care provider (PCP) knowledge and beliefs about PRS, patient activation in healthcare, medication adherence, and costs.

Eligibility criteria: 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

Primary outcomes:
measure: Time-to-new diagnosis of common complex disease
timeFrame: 24 months after enrollment
Secondary outcomes:
measure: Diagnostic testing
timeFrame: 24 months after enrollment
measure: Patient activation
timeFrame: Baseline and 24 months after enrollment
measure: Healthcare costs
timeFrame: 24 months after enrollment
measure: Medication adherence
timeFrame: Baseline and 24 months after enrollment
Other outcomes:
measure: Provider knowledge and beliefs about PRS
timeFrame: 24 months after enrollment
measure: Blood pressure
timeFrame: Baseline and 24 months after enrollment
measure: Body-mass index (BMI)
timeFrame: Baseline and 24 months after enrollment
measure: Aspirin use
timeFrame: Baseline and 24 months after enrollment
measure: Physical activity
timeFrame: Baseline and 24 months after enrollment.
measure: Alcohol intake
timeFrame: Baseline and 24 months after enrollment
measure: Processed meat consumption
timeFrame: Baseline and 24 months after enrollment
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline and 24 months after enrollment
measure: Smoking status
timeFrame: Baseline and 24 months after enrollment
measure: Risk-reducing medication prescriptions
timeFrame: 24 months after enrollment
measure: Health status and quality of life
timeFrame: Baseline and 24 months after enrollment
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Jason L. Vassy, MD, MPH, SM
role: PRINCIPAL_INVESTIGATOR
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