Child Development and Genetic Biomarkers(II): Gene Verification and Data Integration

NCT ID: NCT06532721

Last Updated: 2024-08-29

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

525 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2025-11-30

Brief Summary

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The aims of the study include (1) identifying genes associated with child development and developmental delay in Taiwan (2) comparing the differences and similarities between genetic biomarkers of development and developmental delay for children in Taiwan and children from other countries (3) employing precision medicine as the method for genetic screening or test and (4) tracking children's biological, psychological and social adjustment, especially for those who have early-onset developmental delay.

Detailed Description

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The aims of the study include (1) identifying genes associated with child development and developmental delay in Taiwan (2) comparing the differences and similarities between genetic biomarkers of development and developmental delay for children in Taiwan and children from other countries (3) employing precision medicine as the method for genetic screening or test and (4) tracking children's biological, psychological and social adjustment, especially for those who have early-onset developmental delay.

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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Developmental Disabilities

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* Consent signing
* 0-40 years old
* Typical development or developmental disabilities

Exclusion Criteria

* Central Nervous disease
* Neuromuscular disease
* Congenital disease
* Sensory disorder such as blindness or hearing impairment
Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chia-Ling Chen, MDPhD

Role: CONTACT

88633281200 ext. 8148

Facility Contacts

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ChiaLing Chen

Role: primary

88633281200 ext. 8148

Other Identifiers

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GENE-CGMH 2023 (DD)

Identifier Type: -

Identifier Source: org_study_id

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