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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05318222
Other study ID # H-50430
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date January 31, 2024

Study information

Verified date April 2024
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Inadequate access to genetics evaluation and genomic testing in the Hispanic minorities living along the Texas-Mexico has marginalized the most vulnerable pediatric group. In this study, we will (1) implement a virtual web-based service, called Consultagene for simplifying patient pathways and deliver virtual genetics evaluation in Rio Grande Valley (RGV) (2) provide rapid genetic diagnoses through whole genome sequencing and interpretation of diagnostic studies for medical decision-making and improving health outcomes for the minorities, and (3) build genomic competency of front-line healthcare providers through education and machine learning to expedite referral of pediatric patients with suspected rare diseases for shortening diagnostic odyssey.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 18 Years
Eligibility Inclusion Criteria: Pediatric patients with undiagnosed rare genetic diseases residing in the Rio Grande Valley in Texas Exclusion Criteria: Children with known genetic diseases

Study Design


Intervention

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

Locations

Country Name City State
United States University of Texas Rio Grande Valley Edinburg Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to diagnosis 12 months
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