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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months after enrollment

Awards & highlights

GenoVA Trial 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.Check my eligibility

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.See study design

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.

GenoVA Trial 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.

GenoVA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time-to-new diagnosis of common complex disease

Secondary outcome measures

Diagnostic testing

Healthcare costs

Medication adherence

+1 more

Other outcome measures

Alcohol intake

Aspirin use

Blood pressure

+8 more

GenoVA 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Harvard Medical SchoolLead Sponsor

29 Previous Clinical Trials

39,773 Total Patients Enrolled

Harvard Medical School (HMS and HSDM)Lead Sponsor

195 Previous Clinical Trials

1,314,969 Total Patients Enrolled

Boston VA Research Institute, Inc.Lead Sponsor

22 Previous Clinical Trials

9,730 Total Patients Enrolled

Media Library

Polygenic risk score (PRS) (Polygenic Risk Score) Clinical Trial Eligibility Overview. Trial Name: NCT04331535 — N/A

Type 2 Diabetes Research Study Groups: Polygenic risk score (PRS) - high risk stratum, Usual care (UC) - high risk stratum, Polygenic risk score (PRS) - average risk stratum, Usual care (UC) - average risk stratum

Type 2 Diabetes Clinical Trial 2023: Polygenic risk score (PRS) Highlights & Side Effects. Trial Name: NCT04331535 — N/A

Polygenic risk score (PRS) (Polygenic Risk Score) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04331535 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this clinical trial that would permit enrollment?

"Clinicaltrials.gov indicates that this investigation is presently recruiting participants from the public. The initial posting of this trial was on July 17th 2020, with its most recent edit occurring September 29th 2022."

Answered by AI

What criteria must participants satisfy in order to join this experiment?

"Individuals aged 50 to 70 who have type 2 diabetes mellitus can apply for this medical trial. There are a total of 1076 spots available in the study."

Answered by AI

How many participants may enroll in this medical experiment?

"Affirmative. The clinicaltrials.gov page for this trial reveals that it is actively searching for participants, with the initial posting having been made on July 17th 2020 and a recent update being applied to September 29th 2022. To complete their research objectives, they require 1076 enrollees from only one site."

Answered by AI

Does this clinical investigation permit involvement from individuals over 25 years old?

"As per the requirements of this experiment, applicants must be between 50 and 70 years old. Additionally, there are 240 studies for minors under 18 and 5278 trials aimed at individuals over 65 years old."

Answered by AI