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NCT05990179 · ClinicalTrials.gov registry record · NA
Genomic Uniformed-Screening Against Rare Disease In All Newborns
A NA study of Early Onset Genetic Conditions With Near Complete Penetrance, sponsored by Columbia University.
- Recruiting
- Registry status
- NA
- Development phase
- 100,000
- Enrollment target
- 1
- Study location
NCT05990179 is a NA study of Early Onset Genetic Conditions With Near Complete Penetrance that is actively recruiting participants, run by Columbia University. The registered enrollment target is 100,000 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05990179, a NA study of Early Onset Genetic Conditions With Near Complete Penetrance, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- NA
- Development phase
- 100,000 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to learn how genomic sequencing technology can be used to effectively expand the conditions screened on newborn screening. Newborn screening ensures equity and allows all babies to have the same chance at the healthiest life. Families will be invited to have their newborn baby screened for additional conditions beyond what all babies are screened for as part of the newborn screening public health program. Families can choose to be part of the study or choose not to be part of the study and just have the routine newborn screening test. Families will also be able to choose to learn about their baby's risk for conditions that have effective treatments available but are not on the routine newborn screening panel or also learn about conditions for which there is not currently FDA approved medications but for which medications are under development or for which early intervention services or treatment of seizures may improve the child's outcome. Families will be invited to the study shortly after the baby is born and will learn the decision not to participate, and we will interview a subset of parents who agree to be interviewed. Newborns who screen positive will be referred to appropriate providers for care and will be followed through review of electronic medical records and parental follow up via phone, text, postal mail or email.
Conditions Studied
Interventions
- OTHER Genome sequencing-based newborn screening
Study Locations (1)
New York
- Columbia University Irving Medical Center/NYP - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100,000 participants |
| Start Date | 2022-09-06 |
| Est. Completion | 2029-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05990179
The ClinicalTrials.gov registry entry for NCT05990179 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Early Onset Genetic Conditions With Near Complete Penetrance appearing as the primary indexed condition, and to 1 intervention - of which Genome sequencing-based newborn screening is the first listed.
NCT05990179 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05990179 about?
NCT05990179 is a clinical study titled "Genomic Uniformed-Screening Against Rare Disease In All Newborns". The goal of this study is to learn how genomic sequencing technology can be used to effectively expand the conditions screened on newborn screening. Newborn screening ensures equity and allows all babies to have the same chance at the healthiest life. Families will be invited to have their newborn b...
What is the current status of trial NCT05990179?
This trial is currently recruiting. It is a NA study. The enrollment target is 100,000 participants. The study started on 2022-09-06. Estimated completion is 2029-09.
What conditions does trial NCT05990179 study?
This clinical trial studies the following conditions: Early Onset Genetic Conditions With Near Complete Penetrance.
What interventions are being tested in trial NCT05990179?
The interventions under investigation include: Genome sequencing-based newborn screening (OTHER).
Who is sponsoring clinical trial NCT05990179?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05990179 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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