RECRUITING

Biliary Atresia Study in Infants and Children

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Conditions

Biliary AtresiaCholestasis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Little is known about the factors that cause biliary atresia nor the factors that influence disease progression. The purpose of this study is to collect the pertinent clinical information, genetic material and body fluid samples to enable investigators to address the following aims: To identify the gene or genes implicated in the etiology of BA; To characterize the natural history of the older, non-transplanted child with BA.

Official Title

Biliary Atresia Study in Infants and Children (BASIC)

Quick Facts

Study Start:2006-05-16
Study Completion:2029-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00345553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants need to have a confirmed diagnosis of BA determined by chart review including review of pertinent diagnostic biopsy reports, radiologic reports and surgical reports (if surgery was performed).
  2. 2. Participants need to be \>6 months of age up to and equal to the age of 20 (participants enrolled at 20 years of age will have one visit).
  3. 3. Participants with their native liver.
  4. 4. Parent, guardian or participant (if 18 years of age or older) is willing to provide informed consent and, when appropriate, the participant is willing to assent.
  1. 1. Currently participating in the ChiLDReN study PROBE.
  2. 2. Inability to confirm original diagnostic evaluation of biliary atresia.
  3. 3. Inability or unwillingness of family or participant to participate in all scheduled visits.
  4. 4. History of liver transplantation.

Contacts and Locations

Study Contact

Terese A Howell, BS
CONTACT
734-476-5340
terri.howell@arborresearch.org
Melissa Sexton, BBA
CONTACT
734-693-3811
melissa.sexton@arborresearch.org

Principal Investigator

Sanjiv Harpavat, MD
STUDY_CHAIR
Texas Children's/Baylor College of Medicine
Ed Doo, MD
STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
John C Magee, MD
PRINCIPAL_INVESTIGATOR
University of Michigan
Lisa Henn, PhD
PRINCIPAL_INVESTIGATOR
Arbor Research Collaborative for Health - Data Coordinating Center
Katrina Loh, MD
STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

Children's Hospital of Los Angeles
Los Angeles, California, 90027
United States
University of California at San Francisco
San Francisco, California, 94143
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Children's Healthcare of Atlanta - Emory University
Atlanta, Georgia, 30322
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614
United States
Riley Children's Hospital
Indianapolis, Indiana, 46202
United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
Mount Sinai Medical Center
New York, New York, 10029
United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
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

Collaborators and Investigators

Sponsor: Arbor Research Collaborative for Health

  • Sanjiv Harpavat, MD, STUDY_CHAIR, Texas Children's/Baylor College of Medicine
  • Ed Doo, MD, STUDY_DIRECTOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • John C Magee, MD, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Lisa Henn, PhD, PRINCIPAL_INVESTIGATOR, Arbor Research Collaborative for Health - Data Coordinating Center
  • Katrina Loh, MD, STUDY_DIRECTOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2006-05-16
Study Completion Date2029-05-31

Study Record Updates

Study Start Date2006-05-16
Study Completion Date2029-05-31

Terms related to this study

Keywords Provided by Researchers

  • Biliary Atresia
  • Cholestasis

Additional Relevant MeSH Terms

  • Biliary Atresia