← Back to Search

Genetic Testing

Genomic Risk Assessment for Genetic Disorders (eMERGE Trial)

N/A
Recruiting
Led By Josh Peterson, MD, MPH
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children aged 3 to under 18
Adults aged 18-75
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 12 months post return of results to participant
Awards & highlights

eMERGE Trial Summary

This trial will test a new method to identify people at high risk for specific diseases and recommend individualized approaches to prevention and care.

Who is the study for?
This trial is for adults aged 18-75 and children aged 3-17 who can understand English or Spanish. Participants must be willing to receive a GIRA report and have a healthcare provider to share results with. It's not open to eMERGE staff, non-patients of the institution, those unable to consent, or recent transplant or transfusion recipients.Check my eligibility
What is being tested?
The study tests a Genome Informed Risk Assessment (GIRA) tool that uses genetic data, family history, and clinical information to assess disease risk and suggest personalized prevention strategies across ten diverse sites.See study design
What are the potential side effects?
Since this trial involves risk assessment rather than medication or procedures, traditional side effects are not applicable. However, receiving personal genetic risk information may have psychological impacts such as anxiety.

eMERGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 3 and 17 years old.
Select...
I am between 18 and 75 years old.

eMERGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 12 months post return of results to participant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 12 months post return of results to participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of new health care actions after return of the genome-informed risk assessment
Secondary outcome measures
Number of newly diagnosed conditions after return of the genome-informed risk assessment
Number of risk-reducing interventions after return of the genome-informed risk assessment

eMERGE Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants receiving a Genome Informed Risk Assessment (GIRA)Experimental Treatment1 Intervention
All participants and their health care providers will receive a Genome Informed Risk Assessment (GIRA) report.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
646,068 Total Patients Enrolled
Josh Peterson, MD, MPHPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Genome Informed Risk Assessment (GIRA) report (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT05277116 — N/A
Genetic Disorder Research Study Groups: Participants receiving a Genome Informed Risk Assessment (GIRA)
Genetic Disorder Clinical Trial 2023: Genome Informed Risk Assessment (GIRA) report Highlights & Side Effects. Trial Name: NCT05277116 — N/A
Genome Informed Risk Assessment (GIRA) report (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05277116 — N/A

Frequently Asked Questions

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

Is this research endeavor open to individuals who have surpassed their diamond jubilee?

"This experiment has an age range specification of 3 to 75 years old, which defines the minimum and maximum eligibility requirements."

Answered by AI

How many participants are involved in this clinical venture?

"To be successful, this clinical trial needs to enroll 25000 eligible applicants. Potential participants can find sites offering the study in cities such as Boston and Birmingham. Specifically, Massachusetts General Hospital in Boston and University of Alabama Birmingham are two options for enrolment."

Answered by AI

Is this trial accessible to patients in North America through multiple locations?

"Massachusetts General Hospital in Boston, University of Alabama Birmingham in Birmigham, and Mount Sinai in New york are three sites actively enrolling patients for this trial. Additionally, 12 other medical centres across the country have been added to the recruitment list."

Answered by AI

Is recruitment open for this trial?

"As per information available on clinicaltrials.gov, this experiment is actively looking for enrollees. It was first introduced to the public on February 16th 2022 and most recently updated on October 14th of that same year."

Answered by AI

Am I eligible to be part of this trial?

"For consideration in this medical study, participants must have a genetic disorder and be aged between 3 to 75. Currently, the team is actively recruiting 25 000 individuals for the trial."

Answered by AI

Who else is applying?

What state do they live in?
Washington
How old are they?
65+
18 - 65
What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~10465 spots leftby Oct 2025