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NCT05205356 · ClinicalTrials.gov registry record
VIGOR: Virtual Genome Center for Infant Health
A clinical trial of Genetic Predisposition to Disease and Genetics Disease, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 750
- Enrollment target
- 10
- Study locations
NCT05205356: Recruiting study of Genetic Predisposition to Disease and Genetics Disease, sponsored by Boston Children's Hospital.
NCT05205356 is a study of Genetic Predisposition to Disease and Genetics Disease that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 750 participants, below the 182,456-participant average among 11 other Genetic Predisposition to Disease trials with a reported enrollment target (100% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05205356, a study of Genetic Predisposition to Disease and Genetics Disease, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 750 participants
- Enrollment target
- 10
- Study locations
Study Summary
This study will provide rigorous evaluation of implementing a virtual genome center into community clinical settings without highly specialized resources, thereby offering generalizable insights as to how best to implement genomic medicine at scale and for other age groups. This intervention has great potential to address disparities in genomic medicine among low-income and underrepresented minority (URM) populations and will enhance capacity for providers and health systems to utilize highly specialized genomic techniques in their communities. The goal of this study is to achieve equitable access to state-of-the-art genomic medical care to sick newborns in community centers that predominately care for low-income and racial/ethnic minority populations through the creation of a virtual genome center (VIGOR). VIGOR will provide a venue for physician and family education, genomic expert consultation, reanalysis of unsolved sequencing data, and access to cutting edge therapeutic innovation, thereby facilitating institutionalization of genomic best practices in community settings, and not just highly specialized referral centers.
Primary Outcome
Penetration of VIGOR measured by percentage of eligible participants who were enrolled, tested, providers received CIR and completed a disclosure session.
Conditions Studied
Study Locations (10)
Texas
- Driscoll Children's Hospital Rio Grande Valley - Edinburg
- The Women's Hospital at Renaissance - Edinburg
- The Hospitals of Providence - El Paso
- University of Texas Medical Branch - Galveston
Massachusetts
- Boston Medical Center - Boston
- Baystate Medical Center - Springfield
- UMass Memorial Hospital - Worcester
Alabama
- USA Children's and Women's Hospital - Mobile
Florida
- Holtz Children's Hospital at Jackson Memorial Medical Center - Miami
New Jersey
- Cooper University Hospital - Camden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2027-03-01 |
What NCT05205356 shows while recruiting
NCT05205356 is an observational study that tracks outcomes without assigning an intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, below the 182,456-participant average among 11 other Genetic Predisposition to Disease trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Genetic Predisposition to Disease appearing as the primary indexed condition, and to 0 interventions.
NCT05205356 lists 10 locations in 5 states (Texas, Massachusetts, Alabama).
Frequently Asked Questions
What is clinical trial NCT05205356 about?
NCT05205356 is a clinical study titled "VIGOR: Virtual Genome Center for Infant Health". This study will provide rigorous evaluation of implementing a virtual genome center into community clinical settings without highly specialized resources, thereby offering generalizable insights as to how best to implement genomic medicine at scale and for other age groups. This intervention has gre...
What is the current status of trial NCT05205356?
This trial is currently recruiting. The enrollment target is 750 participants. The study started on 2022-03-22. Estimated completion is 2027-03-01.
What conditions does trial NCT05205356 study?
This clinical trial studies the following conditions: Genetic Predisposition to Disease, Genetics Disease, Genetics/Birth Defects.
Who is sponsoring clinical trial NCT05205356?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05205356 being conducted?
This trial has 10 study locations across Alabama, Florida, Massachusetts, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05205356's enrollment target sits among peer trials
750 4th of 11 higher than 8 of 11 other Genetic Predisposition to Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Genetic Predisposition to 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.
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