Genetic Inclusion by Virtual Evaluation (GIVE)
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ClinicalTrials.gov Identifier: NCT05318222 |
Recruitment Status :
Completed
First Posted : April 8, 2022
Last Update Posted : April 23, 2024
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Condition or disease | Intervention/treatment | Phase |
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Birth Defects Multiple Congenital Anomaly Neurodevelopmental Disorders | Diagnostic Test: Whole genome sequencing (WGS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Virtual Platforms for Genetics Evaluation in the Medically Underserved |
Actual Study Start Date : | June 1, 2022 |
Actual Primary Completion Date : | January 31, 2024 |
Actual Study Completion Date : | January 31, 2024 |
Arm | Intervention/treatment |
---|---|
WGS arm
All 100 patients recruited will undergo WGS
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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 |
- Time to diagnosis [ Time Frame: 12 months ]
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Ages Eligible for Study: | 1 Day to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Pediatric patients with undiagnosed rare genetic diseases residing in the Rio Grande Valley in Texas
Exclusion Criteria:
Children with known genetic diseases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05318222
United States, Texas | |
University of Texas Rio Grande Valley | |
Edinburg, Texas, United States, 78539 |
Principal Investigator: | Seema Lalani | Baylor College of Medicine |
Responsible Party: | Seema Lalani, Professor, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT05318222 |
Other Study ID Numbers: |
H-50430 |
First Posted: | April 8, 2022 Key Record Dates |
Last Update Posted: | April 23, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Congenital Abnormalities Abnormalities, Multiple Neurodevelopmental Disorders Mental Disorders |