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Genetic Testing

Enrollees for Genetic Disorder (BeginNGS Trial)

N/A

Recruiting

Led By Stephen Kingsmore, MD DSc

Research Sponsored by Rady Pediatric Genomics & Systems Medicine Institute

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

BeginNGS Trial Summary

This trial aims to test a new method called BeginNGS for newborn screening using whole genome sequencing. The study will compare the utility, acceptability, feasibility, and cost-effectiveness of BeginNGS

Who is the study for?

This trial is for newborns whose parents consent to enroll them. It's designed to compare a new whole genome sequencing test, BeginNGS, with the standard state newborn screening tests.Check my eligibility

What is being tested?

The BeginNGS Test is being studied to see how useful it is compared to traditional screenings for genetic disorders in newborns. The study will assess its acceptability, feasibility, and cost-effectiveness.See study design

What are the potential side effects?

Since this trial involves a diagnostic test rather than a medication or vaccine, there are no direct side effects from the intervention itself.

BeginNGS 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

Comparison of the clinical utility of BeginNGS and standard of care (state NBS), defined by the proportion of enrollees likely to benefit (likely to have an improved outcome) from an indicated therapeutic intervention

Secondary outcome measures

Acceptability outcome 1

Acceptability outcome 2

Acceptability outcome 3

+26 more

BeginNGS Trial Design

1Treatment groups

Experimental Treatment

Group I: EnrolleesExperimental Treatment1 Intervention

Enrolled infants will receive the BeginNGS test in addition to the state newborn screen.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rady Pediatric Genomics & Systems Medicine InstituteLead Sponsor

8 Previous Clinical Trials

203,853 Total Patients Enrolled

Stephen Kingsmore, MD DScPrincipal InvestigatorRady Children's Institute for Genomic Medicine

1 Previous Clinical Trials

120 Total Patients Enrolled

Rebecca Reimers, MD MPHPrincipal InvestigatorRady Children's Institute for Genomic Medicine

Frequently Asked Questions

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

What is the current number of individuals receiving medical care as part of this clinical trial?

"Yes, current information on clinicaltrials.gov shows that patient recruitment is ongoing for this trial. The trial was first listed on 2/29/2024 and last updated on 3/5/2024. This study aims to enroll 10000 patients from a single site."

Answered by AI

What are the eligibility criteria for individuals interested in participating in this research project?

"Patients with a hereditary condition aged between 24 hours and 4 weeks are eligible for this study, which aims to recruit approximately ten thousand individuals."

Answered by AI

Is the current investigation open for participant enrollment?

"According to details on clinicaltrials.gov, this investigation is currently in search of volunteers. Initially shared on February 29th, 2024, the trial's most recent update was made on March 5th of the same year."

Answered by AI