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NCT06306521 · ClinicalTrials.gov registry record · NA
An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing
A NA study of Genetic Disease, sponsored by Rady Pediatric Genomics & Systems Medicine Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 10,000
- Enrollment target
- 1
- Study location
NCT06306521: Recruiting NA study of Genetic Disease, sponsored by Rady Pediatric Genomics & Systems Medicine Institute.
NCT06306521 is a NA study of Genetic Disease that is actively recruiting participants, run by Rady Pediatric Genomics & Systems Medicine Institute. The registered enrollment target is 10,000 participants, above the 2,228-participant average among 30 other Genetic Disease trials with a reported enrollment target (349% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06306521, a NA study of Genetic Disease, is actively recruiting participants, sponsored by Rady Pediatric Genomics & Systems Medicine Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 10,000 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Parents will be approached to provide informed consent to enroll their newborns in prenatal, postnatal, and outpatient settings. The main questions this study aims to answer are: What is the utility of BeginNGS as compared to state newborn screening? What is the acceptability and feasibility of BeginNGS as compared to state newborn screening? What is the cost effectiveness of BeginNGS as compared to state newborn screening? Enrolled newborns will have a blood sample taken and will receive the BeginNGS test. Newborns will have also had the state newborn screening test.
Primary Outcome
The proportion of enrollees likely to benefit (likely to have an improved outcome) from an indicated therapeutic intervention (as per an electronic clinical management system, Genome-to-Treatment, GTRx)
Conditions Studied
Interventions
- GENETIC BeginNGS Test
Study Locations (1)
California
- Rady Children's Hospital San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,000 participants |
| Start Date | 2024-02-29 |
| Est. Completion | 2029-02 |
| Phase | NA |
What NCT06306521 shows while recruiting
NCT06306521 is an interventional study that assigns participants to a tested intervention. Its 10,000 participants enrollment target places it among the larger protocols in the corpus, above the 2,228-participant average among 30 other Genetic Disease trials with a reported enrollment target (349% higher).
The record links to 1 condition, with Genetic Disease appearing as the primary indexed condition, and to 1 intervention - of which BeginNGS Test is the first listed.
NCT06306521 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06306521 about?
NCT06306521 is a clinical study titled "An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing". The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Parents will be approached to provide informed consent to enroll their newborns in prenatal, postnatal, and outpatient settings. The main questions this study aims to answer ...
What is the current status of trial NCT06306521?
This trial is currently recruiting. It is a NA study. The enrollment target is 10,000 participants. The study started on 2024-02-29. Estimated completion is 2029-02.
What conditions does trial NCT06306521 study?
This clinical trial studies the following conditions: Genetic Disease.
What interventions are being tested in trial NCT06306521?
The interventions under investigation include: BeginNGS Test (GENETIC).
Who is sponsoring clinical trial NCT06306521?
This trial is sponsored by Rady Pediatric Genomics & Systems Medicine Institute, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06306521 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Genetic Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06306521's enrollment target sits among peer trials
10,000 3rd of 30 higher than 27 of 30 other Genetic Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Genetic Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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