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ChiLDReN Genetic Collection Protocol (ChiLDReN-Genetics)

Study Design: Observational
Conditions: Alagille Syndrome, Alpha 1 Anti-Trypsin Deficiency, Bile Duct Diseases, Biliary Atresia, Biliary Tract Diseases, Cholestasis, Hepatitis, Viral, Mitochondrial Disorders
Division: DDN
Duration: 2022-Ongoing
# Recruitment Centers: 14
Available Genotype Data: No
Image Summary: No
Transplant Type: Liver Transplant
Does it have dialysis patients: No
Access to biospecimens for ChiLDReN Genetic Collection Protocol (ChiLDReN-Genetics) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL: https://www.clinicaltrials.gov/study/NCT05272319

General Description

The purpose of this study is to establish a mechanism to collect a genetic biosample from the participants and their biological parents previously enrolled into clinical research under ChiLDReN-supported protocols, A Prospective Database of Infants with Cholestasis (PROBE, NCT00061828); Biliary Atresia Study in Infants and Children (BASIC, NCT00345553); Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC, NCT00571272); and A Longitudinal Study of Mitochondrial Hepatopathies (MITOHEP, NCT01148550). Each of these protocols captures robust clinical longitudinal data and collects specimens to establish repositories to support future research.

Objectives

The major objective of this protocol is to augment a repository of DNA from participants and their biological parents previously enrolled into clinical research but for whom a DNA biosample was not previously collected. The acquisition and storage of DNA from participants and their biological parents will make available an important resource for future and ongoing studies that may evaluate etiology, pathogenesis, biomarkers, pharmacogenomics, and genetic modifiers of these rare disorders.

Outcome Measure

None

Criteria

Inclusion criteria:

For child participants:

Previous enrollment in PROBE, BASIC, LOGIC, or MITOHEP
Exited from one of the aforementioned studies
Consent for DNA sample collection obtained during enrollment during enrollment to one of the aforementioned studies but sample not previously collected
Still followed at the clinical site

For biological parent participants:

Biological parents of previously consented child participant without collection of a parental DNA biospecimen
Child still followed at the clinical site

Exclusion criteria:

For child participants:

Participant is deceased
Participant exited from prior study due to violating eligibility criteria
Participant cannot be contacted

For biological parent participants:

Non-biological parent
Child DNA was not previously collected and will not be collected in this study

Outcome

This study is ongoing.

Resources Available

Specimens Only

Materials Available

DNA

516

Publications (0)

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