Biliary Atresia Study in Infants and Children
ConditionBiliary Atresia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-20
SponsorArbor Research Collaborative for Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
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).
Participants with their native liver.
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.
Disqualifiers
Currently participating in the ChiLDReN study PROBE.
Inability to confirm original diagnostic evaluation of biliary atresia.
Inability or unwillingness of family or participant to participate in all scheduled visits.
History of liver transplantation.
Trial population
Recruitment will be open to any eligible subject. The method of contacting the study subjects will conform to local IRB guidelines, but in general: the parents or guardians of all eligible subjects at each ChiLDReN center, or the subjects themselves if 18 years of age or older, will be approached to participate. New patients who are not participating in ChiLDReN study PROBE may be approached for study participation, but will not be eligible for enrollment until 6 months of age.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,265 Participants
are grouped into 1 trial groupGroup A: 1
Trial outcomes
Primary outcomes
1
To identify the gene or genes implicated in the etiology of BA
The genetics of BA may be investigated on two levels. The first is to identify a group of patients whose etiology is a result of a genetic defect and the second is to examine the influence of genetics on disease acquisition.
Time frame
Specimens for this aim are collected once during study, usually at baseline.Secondary outcomes
1
Define the natural history of the older, non-transplanted child with biliary atresia
Understanding the natural history of a disease is a prerequisite to interpreting disease severity, identifying patterns of illness, identifying early predictors of outcome and understanding the advantages or trade-offs of therapeutic interventions.
Time frame
Observational information collected at entrance into study as well as at each yearly follow-up visit.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Arbor Research Collaborative for Health
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov