Understanding Biliary Atresia in Children
Biliary Atresia Study in Infants and Children (BASIC)
This study is trying to learn more about biliary atresia in children by collecting health information and samples to see what causes the disease and how it affects their lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1265 (estimated) |
| Ages | 6 Months to 20 Years |
| Sex | All |
| Sponsor | Arbor Research Collaborative for Health Academic / other |
| Locations | 16 sites (Los Angeles, California and 15 other locations) |
| Trial ID | NCT00345553 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather clinical information, genetic material, and body fluid samples from children diagnosed with biliary atresia (BA) to explore the causes and progression of the disease. It focuses on identifying genetic defects and autoimmune factors that may contribute to BA and its complications. The study also seeks to characterize the natural history of older children with BA, examining how sentinel events like variceal bleeding and growth failure may predict outcomes such as liver transplantation or mortality. By comparing these children to healthy controls, the study aims to enhance understanding of the disease's impact on quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 months to 20 years with a confirmed diagnosis of biliary atresia.
Not a fit: Patients currently participating in the ChiLDReN study PROBE or those unable to confirm their original diagnostic evaluation of biliary atresia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of biliary atresia, potentially enhancing patient outcomes.
How similar studies have performed: While there have been studies on biliary atresia, this approach focusing on older children and genetic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. 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. Participants with their native liver. 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. Exclusion Criteria: 1. Currently participating in the ChiLDReN study PROBE. 2. Inability to confirm original diagnostic evaluation of biliary atresia. 3. Inability or unwillingness of family or participant to participate in all scheduled visits. 4. History of liver transplantation.
Where this trial is running
Los Angeles, California and 15 other locations
- Children's Hospital of Los Angeles — Los Angeles, California, United States (Recruiting)
- University of California at San Francisco — San Francisco, California, United States (Completed)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Children's Healthcare of Atlanta - Emory University — Atlanta, Georgia, United States (Recruiting)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Riley Children's Hospital — Indianapolis, Indiana, United States (Completed)
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Completed)
- Washington University School of Medicine — St Louis, Missouri, United States (Completed)
- Mount Sinai Medical Center — New York, New York, United States (Completed)
- Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Texas Children's Hospital (Baylor College of Medicine) — Houston, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
- Hospital for Sick Children — Toronto, Ontario, Canada (Completed)
Study contacts
- Principal investigator: John C Magee, MD — University of Michigan
- Study coordinator: Terese A Howell, BS
- Email: terri.howell@arborresearch.org
- Phone: 734-476-5340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.