Biliary Atresia Study in Infants and Children



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any - 20
Updated:2/24/2019
Start Date:May 2006
End Date:May 2019
Contact:Joanne Lord, LPN,BA,CCRC
Email:joanne.lord@arborresearch.org
Phone:734-369-9965

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Biliary Atresia Study in Infants and Children (BASIC)

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.

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.

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 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.

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.
We found this trial at
16
sites
555 University Avenue
Toronto, Ontario M5G 1X8
Phone: 416-813-7654
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Kasper Wang, MD
Phone: 323-361-4566
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Kathy Loomes, MD
Phone: 215-590-2525
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-585-9495
University of Utah Research is a major component in the life of the U benefiting...
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Atlanta, Georgia 30322
Principal Investigator: Saul Karpen, MD PhD
Phone: 404-785-0421
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Atlanta, GA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Ronald J Sokol, MD
Phone: 720-777-4690
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Baltimore, Maryland 21287
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Estella Alonso, MD
Phone: 312-227-3523
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Cincinnati, Ohio 45229
Principal Investigator: Jorge Bezerra, MD
Phone: 513-636-7818
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Houston, Texas 77030
Principal Investigator: Paula Hertel, MD
Phone: 832-822-1053
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Indianapolis, Indiana 46202
Principal Investigator: Jean Molleston, MD
Phone: 317-944-9605
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Indianapolis, IN
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Pittsburgh, Pennsylvania 15224
Principal Investigator: Robert Squires, MD
Phone: 412-692-7703
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94143
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Karen Murray, MD
Phone: 206-987-1037
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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