1011003514 Biliary Atresia Study in Infants and Children (BASIC)

JM

Jean Molleston, MD

Principal Investigator

Status: Enrolling By Invitation Ages: 6 Months - 20 Years Gender: All Genders Phase: N/A 2 Locations

Brief 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 medical information on children with Biliary Atresia so that researchers will be able to learn more about the natural history of Biliary Atresia and its causes. This study will be performed by the Childhood Liver Disease Research Network (ChiLDReN), a National Institute of Diabetes & Digestive and Kidney Diseases (NIDDK) funded network.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - 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.

Detailed Description

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. 
 
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.
 
Biospecimen Description: Samples of blood will be collected for research purposes.

Eligibility of study

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.

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.