Genetic Collection Protocol

NCT05272319 | Completed DMC

• 1 other identifier: Genetic Collection - ChiLDReN
• Study Type: observational
• Target: 171
• Locations: 2 countries
• Sites: 13

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.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 24 Hours - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• For Child Participants
• Previous enrollment in PROBE or BASIC
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Arbor Research Collaborative for Health: lead

Study Sites (13)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

UCSF Benioff Children's Hospital

San Francisco, California, 94143, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Children's Hospital; Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1XG, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Participants will have one-time collection of whole blood or saliva for DNA

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Ed Doo, MD

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  STUDY DIRECTOR

• Katrina Loh, MD

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  STUDY DIRECTOR

• John Magee, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Lisa Henn, PhD

  Arbor Research Collaborative for Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: March 9, 2022
• Study Start: April 6, 2022
• Primary Completion: May 27, 2026
• Study Completion: May 27, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-06

Locations

US (12); CA (1)