Genetic Collection Protocol

Recruiting

• Conditions: Liver Diseases

• Registration Number: NCT05272319
• Lead Sponsor: Arbor Research Collaborative for Health

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-09
• Study Start: 2022-04-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21
• Primary Completion: 2029-05-31
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2230

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Augment a repository of DNA	beginning of study through study completion, an average of 1 year.	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.

Trial Locations

Locations (13)

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

UCSF Benioff Children's Hospital; 🇺🇸 San Francisco, California, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

UPMC Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Texas Children's Hospital; Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada