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NCT07005700 · ClinicalTrials.gov registry record · NA
Rapid Diagnostics for Genetic Disorders in Neonates
A NA study, sponsored by Sharp HealthCare.
- Not yet
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT07005700: Clinical Trial NA study, sponsored by Sharp HealthCare.
NCT07005700 is a NA study that has not yet begun recruiting, run by Sharp HealthCare. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07005700, a NA study, has not yet begun recruiting, sponsored by Sharp HealthCare.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
The goal of this study is to test a prototype genomic blood analysis for identifying rare diseases in infants hospitalized in the neonatal intensive care unit (NICU). The main question it aims to answer is: Does the prototype accurately identify genetic variation(s) associated with an infant's health condition? Researchers will compare the prototype's gene identification to traditional genome sequencing methods of gene identification. Participants will be asked to provide a very small (one-tenth of a teaspoon) sample of blood, one-time.
Primary Outcome
A finding that a participant has one of the genes among the 254 included in the targeted gene panel being used. These genes are associated with metabolic, lysosomal storage, immunodeficiency, hemoglobinopathy, and channelopathy diseases, sensorineural hearing loss, and other conditions typically exposed through newborn screening.
Interventions
- DIAGNOSTIC_TEST Targeted genomic sequencing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-06-30 |
| Est. Completion | 2027-05 |
| Phase | NA |
What is known before NCT07005700 opens enrollment
NCT07005700 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Targeted genomic sequencing is the first listed.
NCT07005700 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07005700 about?
NCT07005700 is a clinical study titled "Rapid Diagnostics for Genetic Disorders in Neonates". The goal of this study is to test a prototype genomic blood analysis for identifying rare diseases in infants hospitalized in the neonatal intensive care unit (NICU). The main question it aims to answer is: Does the prototype accurately identify genetic variation(s) associated with an infant's heal...
What is the current status of trial NCT07005700?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2025-06-30. Estimated completion is 2027-05.
What interventions are being tested in trial NCT07005700?
The interventions under investigation include: Targeted genomic sequencing (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07005700?
This trial is sponsored by Sharp HealthCare, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07005700's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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