Child Development and Genetic Biomarkers(II): Gene Verification and Data Integration
NCT ID: NCT06532721
Last Updated: 2024-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
525 participants
OBSERVATIONAL
2022-12-01
2025-11-30
Brief Summary
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Detailed Description
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The study will be completed in two phases over three years and will enroll a total of 475 0\~40-year-old participants. In the first phase, we will recruit 380 participants. Including 50 participants with typical development, 300 participants with developmental delay and 30 parents to whom have children with severe DD. Then, their genetic data will be compared with genetic data of Chang Gung Hospital and the National Center for Genome Medicine, expect to preliminary find genes associated with child language development. At the same time, 20-30 children with severe developmental delay or have family history of developmental delay will be selected as a pilot study, using whole-exome sequencing (WES) to find other genes associated with development. If the gene deficiency was found in the children, we will invite his or her parents to do WES. In the second phase, we will establish a gene panel according to the genes identified in the previous stage and recruit 95 children with developmental delay to test the gene panel prospectively. The long-term goal of this study is to establish a pioneer study for children
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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developmental disabilities group
this group recruited children with developmental disabilities
No interventions assigned to this group
typical developmental group
This regoup recruited children with typical development
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 0-40 years old
* Typical development or developmental disabilities
Exclusion Criteria
* Neuromuscular disease
* Congenital disease
* Sensory disorder such as blindness or hearing impairment
40 Years
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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ChiaLing Chen
Role: PRINCIPAL_INVESTIGATOR
Chang Gung University
Locations
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Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GENE-CGMH 2023 (DD)
Identifier Type: -
Identifier Source: org_study_id
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