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Polygenic Risk Score

Polygenic Risk Score Testing for High Genetic Risk of Diseases (GenoVA Trial)

N/A

Recruiting

Led By Jason L. Vassy, MD, MPH, SM

Research Sponsored by Harvard Medical School

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

No known diagnosis of coronary artery disease, atrial fibrillation, type 2 diabetes, colorectal cancer, breast cancer, or prostate cancer

Must not have

Known diagnosis of at least one of the six diseases of interest

Younger than age 50 or older than age 70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months after enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well polygenic risk score testing works in patients who are at high genetic risk for certain diseases.

Who is the study for?

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.

What is being tested?

The study is testing the effectiveness of polygenic risk score (PRS) testing in predicting the development of six different diseases over two years. It aims to see if PRS can help identify these conditions earlier among people at high genetic risk.

What are the potential side effects?

Since this trial involves genetic testing rather than medication or procedures, there are no direct physical side effects from the intervention itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have a history of heart disease, irregular heartbeat, diabetes, or cancer.

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I have no history of heart disease, diabetes, or certain cancers.

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I am between 50 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with one of the six specified diseases.

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I am under 50 or over 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 24 months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 24 months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 months after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time-to-new diagnosis of common complex disease

Secondary study objectives

Diagnostic testing

Healthcare costs

Medication adherence

+1 more

Other study objectives

Alcohol intake

Aspirin use

Blood pressure

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Polygenic risk score (PRS) - high risk stratumExperimental Treatment1 Intervention

Patient-participants in the PRS-high arm and their providers will receive their high-PRS results at baseline, along with educational resources about the results.

Group II: Polygenic risk score (PRS) - average risk stratumExperimental Treatment1 Intervention

Patient-participants in the PRS-average arm and their providers will receive their average-PRS results at baseline, along with educational resources about the results.

Group III: Usual care (UC) - high risk stratumActive Control1 Intervention

Patient-participants in the UC-high arm and their providers will receive their high-PRS results after a 24-month observation period, along with educational resources about the results.

Group IV: Usual care (UC) - average risk stratumActive Control1 Intervention

Patient-participants in the UC-average arm and their providers will receive their average-PRS results after a 24-month observation period, along with educational resources about the results..

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Harvard Medical SchoolLead Sponsor

29 Previous Clinical Trials

39,583 Total Patients Enrolled

Harvard Medical School (HMS and HSDM)Lead Sponsor

204 Previous Clinical Trials

1,315,609 Total Patients Enrolled

Boston VA Research Institute, Inc.Lead Sponsor

23 Previous Clinical Trials

9,770 Total Patients Enrolled

VA Boston Healthcare SystemFED

70 Previous Clinical Trials

969,489 Total Patients Enrolled

Jason L. Vassy, MD, MPH, SM1.01 ReviewsPrincipal Investigator - Harvard Medical School (HMS and HSDM)

Harvard Medical School

1Patient Review

Dr. Vassy was dismissive and rude from the start. He shushed me — like I was a child — three times while I was trying to explain my situation. He was also unfamiliar with my disease and seemed uninterested in learning about it or helping me manage my pain.