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Your DNA could predict your health risks — a massive trial puts it to the test

NCT ID NCT05277116

Prevention Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study tests whether a comprehensive genomic risk report, which combines genetic markers, family history, and clinical data, can identify people at high risk for certain diseases and prompt preventive actions. Researchers will enroll over 26,000 diverse adults and children across ten sites, providing each participant with a personalized risk assessment. The goal is to see if this information leads to new health care actions, such as screenings or referrals, and ultimately improves early detection and prevention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Genome Informed Risk Assessment (GIRA) report combining genetic, family history, and clinical risk information
What this could lead to
If successful, this could make genomic screening a routine part of preventive care, helping catch high-risk individuals early and tailor prevention strategies.
What could go wrong
The study is observational and early, so it may not show clear benefits. There are also risks of genetic information causing anxiety or leading to unnecessary medical procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

26,877 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults 18-75 * Children 3 to \< 18 * Able to read or understand English or Spanish * Able to provide a healthcare provider or clinician to receive results * Willing to accept GIRA report Exclusion Criteria: * Inability to provide consent * Transplant (solid organ or bone marrow) or transfusion within 8 weeks * Research staff and investigators in eMERGE * Not a patient at parent institution

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Conditions

The condition(s) this trial relates to.

hereditary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Genetic disease

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Columbia University

    New York, New York, 10032, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • Mountain Park Health Center

    Tempe, Arizona, 85012, United States

  • Northwestern

    Chicago, Illinois, 60611, United States

  • University of Alabama Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203, United States

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