Genetic Collection Protocol

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases

Detailed Description

The purpose of this study is to establish a mechanism to collect a genetic biosample from the participants previously enrolled into clinical research under ChiLDReN-supported protocols (PROBE and BASIC). 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 Type: Observational
• Enrollment (Actual): 213

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1XG
      • The Hospital for Sick Children
• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
    • San Francisco, California, United States, 94143
      • UCSF Benioff Children's Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital; Baylor College of Medicine
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The eligible study population are those child participants who signed consent to participate in a prior research study that collects DNA biospecimens and for whom the specimen was never obtained. If those participants are still followed by the site.

Description

Inclusion Criteria:

• For Child Participants

  1. Previous enrollment in PROBE or BASIC
  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.

     Exclusion Criteria:

  1. Participant is deceased
  2. Participant exited from prior study due to violating eligibility criteria
  3. Participant cannot be contacted

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Augment a repository of DNA	The major objective of this protocol is to augment a repository of DNA from participants previously enrolled into clinical research but for whom a DNA biosample was not previously collected. The acquisition and storage of DNA from participants 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.

Collaborators and Investigators

• Sponsor: Arbor Research Collaborative for Health
• Investigators: Study Director: Ed Doo, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Principal Investigator: John Magee, MD, University of Michigan; Principal Investigator: Lisa Henn, PhD, Arbor Research Collaborative for Health; Study Director: Katrina Loh, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): May 27, 2026
• Study Completion (Actual): May 27, 2026

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: Genetic Collection - ChiLDReN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No