Liver DiseasesNCT05272319
Genetic Collection Protocol
An observational study of Liver Diseases, run by Arbor Research Collaborative for Health at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 hours to 25 years
- Conditions the study is for
- Liver Diseases
- How many people
- 171 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 6 Apr 2022to 27 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 25 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
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- Participant is deceased
- Participant exited from prior study due to violating eligibility criteria
- Participant cannot be contacted
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
Lurie Children's Hospital
Chicago, Illinois, 60611
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Texas Children's Hospital; Baylor College of Medicine
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Hospital of Los Angeles
Los Angeles, California, 90027
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
University of Utah
Salt Lake City, Utah, 84113
UCSF Benioff Children's Hospital
San Francisco, California, 94143
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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.
Read the 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.
- Conditions
- Liver Diseases
- Medical subject headings
- Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: beginning of study through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start6 Apr 2022
- Primary completion27 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Research Collaborative for Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ed Doo, MD, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Katrina Loh, MD, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)John Magee, MD, Principal investigator, University of MichiganLisa Henn, PhD, Principal investigator, Arbor Research Collaborative for Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272319
- Sponsor's protocol ID
- Genetic Collection - ChiLDReN
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2021
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Collection Protocol
- ClinicalTrials.gov ID
- NCT05272319
- Acronym / sponsor ID
- Genetic Collection - ChiLDReN
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Arbor Research Collaborative for HealthUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 24 hours to 25 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- For Child Participants
Key exclusion criteria (4 listed)
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed Doo, MD study director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Katrina Loh, MD study director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
John Magee, MD principal investigator
University of Michigan
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Arbor Research Collaborative for Health at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Augment a repository of DNA (time frame: beginning of study through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.