Genetic Collection Protocol
1 other identifier
observational
2,230
2 countries
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2021
CompletedFirst Posted
Study publicly available on registry
March 9, 2022
CompletedStudy Start
First participant enrolled
April 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
September 10, 2025
September 1, 2025
7.2 years
December 13, 2021
September 3, 2025
Conditions
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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
UCSF Benioff Children's Hospital
San Francisco, California, 94143, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Texas Children's Hospital; Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
The Hospital for Sick Children
Toronto, Ontario, M5G 1XG, Canada
Biospecimen
Participants will have one-time collection of whole blood or saliva for DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
- PRINCIPAL INVESTIGATOR
John Magee, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Lisa Henn, PhD
Arbor Research Collaborative for Health
Central Study Contacts
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 (Estimated)
May 31, 2029
Study Completion (Estimated)
May 31, 2029
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share