Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genetic Collection Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05272319
Recruitment Status : Recruiting
First Posted : March 9, 2022
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Arbor Research Collaborative for Health

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.

Condition or disease
Liver Diseases

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2230 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Genetic Collection Protocol
Actual Study Start Date : April 6, 2022
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024



Primary Outcome Measures :
  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 and their biological parents previously enrolled into clinical research but for whom a DNA biosample was not previously collected. The acquisition and storage of DNA from participants and their biological parents 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.


Biospecimen Retention:   Samples With DNA
Participants will have one-time collection of whole blood or saliva for DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05272319


Contacts
Layout table for location contacts
Contact: Terri Howell 734-369-9683 thowell@arborresearch.org

Locations
Layout table for location information
United States, California
Children's Hospital of Los Angeles Not yet recruiting
Los Angeles, California, United States, 90027
Contact: Catherine Goodhue, CPNP    323-361-4566    cgoodhue@chla.usc.edu   
Principal Investigator: Kasper Wang, MD         
UCSF Benioff Children's Hospital Not yet recruiting
San Francisco, California, United States, 94143
Contact: Camille Langlois    415-476-1756    langloisc@peds.ucsf.edu   
Contact: Joanna Curry    (415) 476-1756    joanna.curry@ucsf.edu   
Principal Investigator: Phil Rosenthal, MD         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Rodolfo Hernandez    720-777-1294    rodolfo.hernandez@childrenscolorado.org   
Principal Investigator: Ron Sokol         
United States, Georgia
Children's Healthcare of Atlanta Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Katelynn Harris    404-785-0421    katelynn.harris@choa.org   
Principal Investigator: Saul Karpen         
United States, Illinois
Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Sue Kelly, RN    312-227-3523    skelly@luriechildrens.org   
Contact: Mary Riordan    (312) 227-4558    mriordan@luriechildrens.org   
Principal Investigator: Estella Alonso, MD         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Ann Klipsch    317-274-9605    aeye@iupui.edu   
Principal Investigator: Jean Molleston, MD         
United States, Ohio
Cincinnati Children's Hospital Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jennifer Hawkins    513-636-7818    Jennifer.Hawkins@cchmc.org   
Contact: Erin Chapman    (513) 517-7220    erin.chapman@cchmc.org   
Principal Investigator: Jorge Bezerra, MD         
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Motolani Shenbanjo    267-426-8613    shenbanjom@email.chop.edu   
Contact: Katherine Cambareri    (267) 426-8412    CAMBARERIK@EMAIL.CHOP.EDU   
Principal Investigator: Kathleen Loomes, MD         
UPMC Children's Hospital of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Christina Henry    412-692-3905    henryc8@upmc.edu   
Principal Investigator: Simon Horslen, MD         
United States, Texas
Texas Children's Liver Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Laurel Cavallo    832-822-1053    Laurel.Cavallo@bcm.edu   
Sub-Investigator: Benjamin Shneider, MD         
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84113
Contact: Ann Rutherford    801-585-9495    ann.rutherford@hsc.utah.edu   
Principal Investigator: Steve Guthery         
United States, Washington
Seattle Children's Hospital Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Melissa Young    206-987-1037    melissa.young@seattlechildrens.org   
Contact: Kara Cooper    (206) 987-4636    kara.cooper@seattlechildrens.org   
Principal Investigator: Evelyn Hsu, MD         
Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1XG
Contact: Deepika Sharma    (416) 813-7654 x201594    deepika.sharma@sickkids.ca   
Contact: Ramisha Chowdhury    (416) 813-7654 x201594    ramisha.chowdhury@sickkids.ca   
Principal Investigator: Binita Kamath, MD         
Sponsors and Collaborators
Arbor Research Collaborative for Health
Layout table for additonal information
Responsible Party: Arbor Research Collaborative for Health
ClinicalTrials.gov Identifier: NCT05272319    
Other Study ID Numbers: Genetic Collection - ChiLDReN
First Posted: March 9, 2022    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Digestive System Diseases