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RecruitingNCT05318222GIVEUpdated Oct 1, 2026

Genetic Inclusion by Virtual Evaluation

An interventional study of Whole genome sequencing (WGS) in Birth Defects, Multiple Congenital Anomaly and Neurodevelopmental Disorders, sponsored by Baylor College of Medicine. Recruiting at 1 site in United States. Open to participants aged 1 Day to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.

Primary conditionCongenital Abnormalities(the registry's first term)UnverifiedIs this wrong?Congenital Abnormalities is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
1 Day to 18 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Birth Defects
  • Multiple Congenital Anomaly
  • Neurodevelopmental Disorders
03

In context

Congenital Abnormalities Unverified

781 studies on the registry are indexed under Congenital Abnormalities; 77 are open to participants now.

This study's planned enrollment of 200 is above the median of 40 across 466 interventional studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.

Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.

Compared within Congenital Abnormalities, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

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Who can participate

Ages eligible
1 Day to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Pediatric patients with undiagnosed rare genetic diseases residing in the Rio Grande Valley and El Paso in Texas

Exclusion criteria

Exclusion Criteria:

Children with known genetic diseases

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Other
    WGS arm

    All 200 patients recruited will undergo WGS

    Diagnostic Test: Whole genome sequencing (WGS)

Interventions

  • Diagnostic testWhole 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

06

What researchers measure

Primary outcomes

  1. Time to diagnosis

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • University of Texas Rio Grande Valley
    Edinburg, Texas 78539, United States
    Recruiting
08

References and documents

Publications

  • Vuocolo B, Sierra R, Brooks D, Holder C, Urbanski L, Rodriguez K, Gamez JD, Mulukutla SN, Hernandez A, Allegre A, Hidalgo H, Rodriguez S, Magallan S, Gibson J, Bernini JC, Watson M, Nelson R, Mellin-Sanchez L, Garcia N, Berry L, Dai H, Soler-Alfonso C, Carter K, Lee B, Lalani SR. Project GIVE: using a virtual genetics service platform to reduce health inequities and improve access to genomic care in an underserved region of Texas. J Neurodev Disord. 2024 Sep 9;16(1):52. doi: 10.1186/s11689-024-09560-x. PubMed 39251895 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 39251895 ↗
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 39251895 ↗
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT05318222
Responsible party
Seema Lalani (Professor, Baylor College of Medicine) — Principal investigator
First posted
Apr 8, 2022
Start date
Jun 1, 2022
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Oct 1, 2026

Study contacts

Seema Lalani, MD
Contact
seemal@bcm.edu
832-822-4280
Brendan Lee, MD; PhD
Contact
blee@bcm.edu
832-822-4280
Seema Lalani
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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