Summary

Eligibility
for people ages 6 months to 20 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Philip Rosenthal

Description

Summary

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 identify polymorphisms that may be important in disease progression such as HLA polymorphisms; To characterize the natural history of the older, non-transplanted child with BA.

Official Title

Biliary Atresia Study in Infants and Children (BASIC)

Details

Little is known about the factors that cause biliary atresia nor the factors that influence disease progression. A variety of genetic, autoimmune and environmental influences have been hypothesized to be important. Most studies to date have focused on the neonate and young child with BA, yet the older surviving child with BA can provide important information about genetics, as well as, natural history.

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 hypotheses:

Hypothesis 1: A genetic defect is a likely causative factor for BA among children with BA and multiple congenital anomalies.

Hypothesis 2: Autoimmune factors are likely to contribute to disease progression or acquisition and can be identified by correlating HLA among children with BA to healthy controls and by comparison of those who develop early complications including, variceal bleed, ascites, and growth failure compared to those who do not.

Hypothesis 3a: Sentinel events such as variceal bleeding, ascites and growth failure are earlier predictors of death or need for liver transplantation than the pediatric end-stage liver disease score (PELD).

Hypothesis 3b: Health related quality of life will be impaired compared to healthy age matched children and relate to severity of illness.

Hypothesis 3c: Growth failure as measured by anthropometrics and nutritional supplementation will be predictive of onset of sentinel events (ascites, variceal bleed, death, and transplant) in the following 24 months.

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.

Keywords

Biliary Atresia, Cholestasis

Eligibility

You can join if…

Open to people ages 6 months to 20 years

  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 either have their native liver or have a confirmed liver transplantation.
  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.

You CAN'T join if...

  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.

Locations

  • University of California at San Francisco in progress, not accepting new patients
    San Francisco California 94143 United States
  • Children's Hospital of Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84113 United States

Lead Scientist at UCSF

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Arbor Research Collaborative for Health
Links
Childhood Liver Disease Research Network (ChiLDReN) website
ID
NCT00345553
Study Type
Observational
Participants
Expecting 1265 study participants
Last Updated