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Genetic Testing

Treatment for Syndrome (GEMINI Trial)

N/A

Waitlist Available

Led By Jill L Maron, MD, MPH

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

GEMINI Trial Summary

This trial will compare the clinical utility and economic outcomes of rapid whole genomic sequencing (WGS) versus a targeted genomic sequencing panel (GSP) on neonates and infants suspected of having a genetic disorder.

GEMINI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Clinical utility of genomic sequencing as assessed by changes in clinical care management

Perception of the clinical utility of genomic sequencing

The number of subjects with a confirmed genetic disorder detected by NewbornDx

+3 more

Secondary outcome measures

Lifetime cost-effectiveness of SOC, NewbornDx and rWGS testing

One year cost-effectiveness of standard of care (SOC), NewbornDx and rWGS testing

User satisfaction with the clinical reference database providing physician-specific information about treatments, resources and ongoing clinical trials regarding the genetic disorder diagnosed: likert scale

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

N.C. Children's HospitalUNKNOWN

North Carolina Children's HospitalUNKNOWN

University of PittsburghOTHER

1,722 Previous Clinical Trials

16,342,546 Total Patients Enrolled

26 Trials studying Syndrome

7,697 Patients Enrolled for Syndrome

Frequently Asked Questions

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

Is there an age restriction that limits enrollment in this experiment?

"For this medical trial, patients must be between 1 Day and 1 Year years old."

Answered by AI

Are new participants able to enroll in this experiment?

"As reported on clinicaltrials.gov, this study is no longer actively recruiting patients and was last updated on March 11th 2022. Nevertheless, 1 other trial is enrolling participants at the present moment."

Answered by AI

How can I gain admittance to this clinical experimentation?

"This research is recruiting 400 infants aged between 24 hours and 12 months that have a pediatric genetic syndrome. Additionally, they must be under one year in corrected gestational age to qualify for the trial."

Answered by AI

Are there multiple locations in the United States conducting this trial?

"A number of hospitals are contributing to this clinical trial, including the Cincinnati Children's Hospital Medical Center in Ohio, Icahn School of Medicine at Mount Sinai in New york City and Rady Children's Hospital - San Diego in California. Additionally, there are 6 other sites that are partaking in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Genomic Medicine for Ill Neonates and Infants (The GEMINI Study)

2019. "Genomic Medicine for Ill Neonates and Infants (The GEMINI Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03890679.