Clinical trial NCT05272319: Genetic Collection Protocol
Official title: Genetic Collection Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Diseases
Lead sponsor: Arbor Research Collaborative for Health
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 2230
Sex: ALL
Minimum age (years): 24
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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. Biological parents of previously consented child participants without collection of a parental DNA biospecimen will also be included, if their child is still followed by the site.

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 and their biological parents previously enrolled into clinical research under ChiLDReN-supported protocols (PROBE, BASIC, LOGIC, and MITOHEP). 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.

Eligibility criteria: Inclusion Criteria:

* For Child Participants

  1. Previous enrollment in PROBE, BASIC, LOGIC, or MITOHEP
  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.
* For Biological Parent Participants

  1. Biological parents of previously consented child participant without collection of a parental DNA biospecimen.
  2. Child still followed at the clinical site.

Exclusion Criteria:

* For Child Participants

  1. Participant is deceased
  2. Participant exited from prior study due to violating eligibility criteria
  3. Participant cannot be contacted
* For Biological Parent Participants

  1. Non-biological parent
  2. Child DNA was not previously collected and will not be collected in this study

Primary outcomes:
measure: Augment a repository of DNA
timeFrame: beginning of study through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital; Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Ed Doo, MD
role: STUDY_DIRECTOR
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Averell Sherker, MD
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: John Magee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arbor Research Collaborative for Health
name: Lisa Henn, PhD
role: PRINCIPAL_INVESTIGATOR
References: