Biliary Atresia Study in Infants and Children (BASIC)
Study Design: Cohort
Conditions: Biliary Atresia, Liver Diseases
Duration: 2006 – Present
# Recruitment Centers: 16
Treatment: None, observational only
Available Genotype Data: No
Image Summary: No
Transplant Type: Liver Transplant
Does it have dialysis patients: No
Access to samples for Biliary Atresia Study in Infants and Children (BASIC) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT00345553
The Childhood Liver Disease Research and Education Network (ChiLDREN) is a consortium of 16 clinical sites and a data-coordinating center that is committed to research into the etiology, pathogenesis, and treatment of rare pediatric liver diseases. Biliary atresia, one disorder studied by the consortium, is characterized by destruction or discontinuity of the extrahepatic biliary system, which results in obstruction to bile flow. Little is known about either the cause of biliary atresia or the factors that influence disease progression. The Biliary Atresia Study in Infants and Children (BASIC) is a prospective, observational study that was established by ChiLDREN to collect pertinent clinical information and biospecimens to aid in the understanding of the disorder. Specific aims of the study include identifying the gene(s) implicated in the etiology of biliary atresia, identifying the polymorphisms that may influence disease progression, and characterizing the natural history of the older, non-transplanted patients with biliary atresia.
Patients between the ages of 1 and 25 years with a confirmed diagnosis of biliary atresia are eligible to participate in the study. Following enrollment, participants are separated into two cohorts: those who have their native liver and those who have received a liver transplant. Clinical information, including medical history, and biospecimens are collected at baseline. Those with their native liver will have clinical information collected annually for 10 years. Genetic analyses are performed on the biospecimens provided to identify the gene(s) and polymorphisms implicated in the etiology and progression of biliary atresia.
This study is ongoing.
Specific aims of the study include indentifying the gene(s) implicated in the etiology of biliary atresia, identifying the polymorphisms that may influence disease progression, and characterizing the natural history of the older, non-transplanted patients with biliary atresia.
Patients between the ages of 1 and 25 years who meet the following criteria are eligible for enrollment:
- Have a confirmed diagnosis of biliary atresia determined chart review, including review of pertinent diagnostic biopsy reports, radiologic reports and surgical reports.
- Greater than or equal to one year of age
- Have their native liver or have a confirmed liver transplantation
Exclusion criteria are documented in the study protocol.
This study is ongoing.