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Completed

NCT Number: NCT05272319

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.

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Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

24 hour–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Augment a repository of DNA

    Time frame: 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 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.

Sponsors and collaborators

Lead sponsor

Arbor Research Collaborative for Health

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2022
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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