Genetic Inclusion by Virtual Evaluation

Part of paid clinical trials in Edinburg, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05318222
Status
Recruiting

Conditions

  • Birth Defects
  • Multiple Congenital Anomaly
  • Neurodevelopmental Disorders

Eligibility Criteria

Sex
ALL
Age
1 Day - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Whole genome sequencing (WGS) — DIAGNOSTIC_TEST
    WGS will identify copy number variations (CNVs), single nucleotide variants (SNVs), as well as triplet repeat disorders in children with rare diseases

Study Details

This study aims to transform the current clinical practice paradigm by leveraging an internally designed web-based model of delivery of care called Consultagene to provide remote evaluation and genomic sequencing for improving genetic health of less resourced children with rare disorders living along the Texas-Mexico border.

Key Dates

Start date
Jun 1, 2022
Status verified
Jan 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: WGS arm
    All 200 patients recruited will undergo WGS

Primary Outcome Measure

Time to diagnosis [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Rio Grande ValleyEdinburgTexas78539
Lori Berry, MD

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