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Genomic Screening

Genomic Screening for Rare Genetic Conditions in Newborns (GUARDIAN Trial)

N/A

Recruiting

Led By Wendy K. Chung, MD, PhD

Research Sponsored by Columbia University

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 from study launch to end of enrollment (up to 5 years)

Awards & highlights

GUARDIAN Trial Summary

This trial looks at how genomic sequencing can expand newborn screening to detect more conditions & give all babies a chance at a healthier life.

Who is the study for?

This trial is for newborns in well-baby nurseries from certain hospitals, born after 33 weeks of gestation. It's open to babies whose parents speak English, Mandarin, or Spanish. The study aims to screen these babies for additional rare genetic conditions beyond the standard public health screenings.Check my eligibility

What is being tested?

The trial tests genome sequencing-based screening on newborns to detect rare diseases not covered by routine checks. Parents can opt-in for their baby's testing and choose which results they want: only treatable conditions or including those under research.See study design

What are the potential side effects?

There are no direct physical side effects from the genomic screening itself; however, there may be emotional or social impacts due to learning about potential genetic risks.

GUARDIAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study launch to end of enrollment (up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study launch to end of enrollment (up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study launch to end of enrollment (up to 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

Enrollment Rate (percentage)

Screen Positive Rate (percentage)

Successful Sequencing Rate (percentage)

+1 more

Secondary outcome measures

Score on Decision Regret Scale

GUARDIAN Trial Design

1Treatment groups

Experimental Treatment

Group I: Enrolled in the studyExperimental Treatment1 Intervention

All newborns enrolled in the study will be evaluated.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,347,259 Total Patients Enrolled

Illumina, Inc.Industry Sponsor

24 Previous Clinical Trials

54,396 Total Patients Enrolled

GeneDxUNKNOWN

1 Previous Clinical Trials

30,000 Total Patients Enrolled

Media Library

Genome sequencing-based newborn screening (Genomic Screening) Clinical Trial Eligibility Overview. Trial Name: NCT05990179 — N/A

Genetic Conditions Research Study Groups: Enrolled in the study

Genetic Conditions Clinical Trial 2023: Genome sequencing-based newborn screening Highlights & Side Effects. Trial Name: NCT05990179 — N/A

Genome sequencing-based newborn screening (Genomic Screening) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05990179 — N/A

Frequently Asked Questions

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

Is the cut-off age for this clinical trial restricted to those under fifty-five?

"This clinical trial is targeting participants between 1 day and 1 month years old."

Answered by AI

Are there still open participatory slots within this clinical investigation?

"Affirmative, according to the information available on clinicaltrials.gov this experiment is presently recruiting patients. This trial was published on September 6th 2022 and has been updated as recently as August 10th 2023. The goal of these studies is to recruit up to 100000 participants from a single site."

Answered by AI

What characteristics of a participant make them eligible for this research trial?

"The requirements for enrolment into this medical trial necessitates a genetic condition and the age range of 1 Day to 1 Month. Moreover, it is intended to include 100000 participants in total."

Answered by AI

What is the maximum number of participants that this trial will accept?

"Affirmative. Per the information on clinicaltrials.gov, this research project commenced recruitment on September 6th 2022 and has been recently updated on August 10th 2023. The study is hoping to enroll 100000 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Genomic Uniformed-Screening Against Rare Disease In All Newborns

Rudolph L. Leibel 2022. "Genomic Uniformed-Screening Against Rare Disease In All Newborns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05990179.