Genetic Collection Protocol

Liver Diseases Clinical Trial

Official title:

Genetic Collection Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272319
• Other study ID #: Genetic Collection - ChiLDReN
• Status: Recruiting
• Start date: April 6, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Arbor Research Collaborative for Health
• Contact: Terese A Howell, BS
• Phone: 734-476-5340
• Email: terri.howell[@]aborresearch.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study involves the one-time collection of whole blood or saliva samples for the extraction and storage of DNA for use in ongoing and future ChiLDReN studies.

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 (PROBE, BASIC, LOGIC, and MITOHEP). The samples will be linked to the data previously collected on the participant. Samples will be stored in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) specimen repository and will be used in ongoing and future Network and Ancillary Studies of ChiLDReN to further address the pathophysiology and outcomes of these liver diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2230
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Gender: All
• Age group: 24 Hours to 25 Years

Eligibility

Inclusion Criteria:

• For Child Participants

1. Previous enrollment in PROBE, BASIC, LOGIC, or MITOHEP

2. Exited from one of the aforementioned studies.

3. Consent for DNA sample collection obtained during enrollment during enrollment to one of the aforementioned studies but sample not previously collected.

4. Still followed at the clinical site.

• For Biological Parent Participants

1. Biological parents of previously consented child participant without collection of a parental DNA biospecimen.

2. Child still followed at the clinical site.

Exclusion Criteria:

• For Child Participants

1. Participant is deceased

2. Participant exited from prior study due to violating eligibility criteria

3. Participant cannot be contacted

• For Biological Parent Participants

1. Non-biological parent

2. Child DNA was not previously collected and will not be collected in this study

Related Conditions & MeSH terms

• Liver Diseases

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Texas Children's Hospital; Baylor College of Medicine	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Arbor Research Collaborative for Health

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Augment a repository of DNA	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.	beginning of study through study completion, an average of 1 year.