Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532721
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Child Development and Genetic BiomarkersII Gene Verification and Data Integration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Child Development and Genetic BiomarkersII Gene Verification and Data Integration
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childrens biological psychological and social adjustment especially for those who have early-onset developmental delay
Detailed Description:
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 childrens 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 475 040-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
The study will be completed in two phases over three years and will enroll a total of 475 040-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None