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Genetic Collection Protocol

Genetic Collection Protocol

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05272319
Enrollment
171
Registered
2022-03-09
Start date
2022-04-06
Completion date
2026-05-27
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases

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 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.

Interventions

None listed

Sponsors

Arbor Research Collaborative for Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
24 Years to 25 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Augment a repository of DNAbeginning 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 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.

Countries

Canada, United States

Contacts

STUDY_DIRECTOREd Doo, MD

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

STUDY_DIRECTORKatrina Loh, MD

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

PRINCIPAL_INVESTIGATORJohn Magee, MD

University of Michigan

PRINCIPAL_INVESTIGATORLisa Henn, PhD

Arbor Research Collaborative for Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026