Polygenic Risk Score Testing for High Genetic Risk of Diseases
(GenoVA Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.
What data supports the effectiveness of the treatment Polygenic Risk Score Testing for High Genetic Risk of Diseases?
Research shows that polygenic risk scores (PRS) can help predict the risk of complex diseases like heart disease, diabetes, and cancer by combining genetic information. While PRSs are increasingly used in clinical settings, their effectiveness is still being evaluated, and they are not yet widely adopted in routine clinical practice.12345
Is polygenic risk score testing safe for humans?
How is the polygenic risk score treatment different from other treatments for genetic risk of diseases?
Polygenic risk score (PRS) treatment is unique because it uses a person's genetic information to estimate their risk for complex diseases by analyzing thousands of genetic variants, unlike traditional treatments that may not consider genetic factors. This approach can help tailor healthcare decisions based on an individual's genetic susceptibility, offering a more personalized strategy compared to standard treatments.12389
What is the purpose of this trial?
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.
Research Team
Jason L. Vassy, MD, MPH, SM
Principal Investigator
Harvard Medical School (HMS and HSDM)
Eligibility Criteria
This trial is for individuals aged 50-70 who have a high genetic risk but no current diagnosis of coronary artery disease, atrial fibrillation, type 2 diabetes, colorectal cancer, breast cancer, or prostate cancer. Pregnant individuals, those incarcerated or institutionalized, and anyone with a known diagnosis of these diseases cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants and providers receive PRS results and educational resources
Observation
Participants are monitored for changes in clinical management and time-to-diagnosis of diseases
Follow-up
Participants are monitored for safety and effectiveness after the main observation period
Treatment Details
Interventions
- Polygenic risk score (PRS)
Polygenic risk score (PRS) is already approved in United States, European Union for the following indications:
- Coronary artery disease
- Atrial fibrillation
- Type 2 diabetes mellitus
- Colorectal cancer
- Breast cancer
- Prostate cancer
- Cardiovascular diseases
- Diabetes
- Cancer risk assessment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Harvard Medical School
Lead Sponsor
Harvard Medical School (HMS and HSDM)
Lead Sponsor
Boston VA Research Institute, Inc.
Lead Sponsor
VA Boston Healthcare System
Collaborator