The China Neonatal Genomes Project (CNGP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03931707|
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment|
|Newborn Hereditary Disease Genetic Predisposition to Disease Defect, Congenital||Genetic: Genomic sequencing|
|Study Type :||Observational|
|Estimated Enrollment :||100000 participants|
|Official Title:||The China Neonatal Genomes Project|
|Actual Study Start Date :||August 8, 2016|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
Sick Neonatal Cohort, Sequencing
Infants and their parents enrolled through Neonatal Intensive Care Unit of member hospitals who are un-randomized to receive genomic sequencing. Results disclosure sessions will include a discussion of: family history report, results from standard newborn screening, any potentially medically relevant findings from the baby's medical history/physical exam, and the results of the genomic sequencing report.
Genetic: Genomic sequencing
Both sick and high-risk newborn un-randomized to receive genomic sequencing will receive a Genomic Newborn Sequencing Report which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.
- Number of gene sequencing data in neonatal gene bank [ Time Frame: From birth to completion of genetic screening, the process last up to 3 months. ]Each newborn that was sequenced was counted as 1. Keep all the data in the gene bank, and finally calculate the number of completed gene sequencing data.
- Gene mutation rate [ Time Frame: From birth to completion of genetic screening, the process last up to 3 months. ]Taking the number of newborn babies as denominator and the number of neonates with gene mutation detected in gene sequencing as molecules, the whole neonatal gene mutation rate in China was obtained.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931707
|Contact: Wenhao Zhoufirstname.lastname@example.org|
|Contact: Lin Yangemail@example.com|
|Children Hospital of Fudan University||Recruiting|
|Shanghai, Shanghai, China, 201102|
|Contact: Wenhao Zhou, Doctor (+86)021-64931003 firstname.lastname@example.org|
|Study Chair:||Wenhao Zhou||Children's Hospital of Fudan University|