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Biliary Atresia Research Consortium (PROBE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00061828
First received: June 5, 2003
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

Biliary atresia and idiopathic neonatal hepatitis are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Biliary Atresia Research Consortium (BARC) is to establish a database of clinical information and serum and tissue samples from children with biliary atresia (BA) and idiopathic neonatal hepatitis (INH) to facilitate research and to perform clinical, epidemiological and therapeutic trials in these two important pediatric liver diseases.


Condition
Biliary Atresia
Cholestasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Database of Infants With Cholestasis

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention:   Samples With DNA

Samples of blood, urine and liver tissue samples will be collected for research purposes.


Estimated Enrollment: 1000
Study Start Date: May 2004
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Biliary Atresia
Infants presenting with cholestasis who are diagnosed with biliary atresia.
Non-Biliary Atresia
Infants presenting with cholestasis without a diagnosis of biliary atresia.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study population will be selected from the patient base of participating speciality care clinics.

Criteria
  • Age less or equal to 180 days at presentation to clinical site.
  • Clinically meaningful cholestasis due to primary hepatobiliary disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061828

Locations
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Catherine Goodhue, CPNP    323-361-4566    cgoodhue@chla.usc.edu   
Principal Investigator: Kasper Wang, MD         
Sub-Investigator: Nanda Kerker, MD         
Sub-Investigator: Sonia Michail, MD         
Sub-Investigator: Danny Thomas, MD         
University of California Active, not recruiting
San Francisco, California, United States, 94143
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Todd Miller    720-777-5304    todd.miller@childrenscolorado.org   
Contact: Michelle Hite    720-777-4690    michelle.hite@childrenscolorado.org   
Principal Investigator: Ronald Sokol, MD         
Sub-Investigator: Cara Mack, MD         
Sub-Investigator: Michael Narkewicz, MD         
Sub-Investigator: Shikha Sundaram, MD         
United States, Georgia
Children's Healthcare of Atlanta (Emory University) Recruiting
Atlanta, Georgia, United States, 30322
Contact: Dana Hankerson-Dyson    404-785-6027    dana.hankerson-dyson@choa.org   
Contact: Rita Tory    404-785-1467    rita.tory@choa.org   
Principal Investigator: Saul Karpen, MD, PhD         
Sub-Investigator: Nitika Gupta, MD         
Sub-Investigator: Rene Romero, MD         
Sub-Investigator: Miriam Vos, MD MSPH         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60614
Contact: Sue Kelly, RN, BSN    312-227-3523    skelly@luriechildrens.org   
Contact: Elizabeth Kaurs    312-227-4558    ekaurs@luriechildrens.org   
Principal Investigator: Peter Whitington, MD         
Sub-Investigator: Estella Alonso, MD         
Sub-Investigator: Lee Bass, MD         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Cindy Sawyers, BSRT    317-944-1421    clsawyer@iupui.edu   
Contact: Ann Klipsch, RN    317-944-9605    aeye@iupui.edu   
Principal Investigator: Jean Molleston, MD         
Sub-Investigator: Molly Bozic, MD         
United States, Maryland
Johns Hopkins School of Medicine Completed
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington University School of Medicine Completed
St Louis, Missouri, United States, 63110
United States, New York
Mount Sinai Medical Center Completed
New York City, New York, United States, 10029
United States, Ohio
Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Julie Denlinger    513-636-7818    julie.denlinger@cchmc.org   
Contact: Andrea Ferris    5138030675    andrea.ferris@cchmc.org   
Principal Investigator: Jorge Bezerra, MD         
Sub-Investigator: James Heubi, MD         
Sub-Investigator: Alexander Miethke, MD         
Sub-Investigator: Joseph Palermo, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessi Erlichman, MPH    215-590-2525    erlichman@email.chop.edu   
Contact: Lindsay Brown    267-426-0970    brownL7@email.chop.edu   
Principal Investigator: Kathleen Loomes, Loomes, MD         
Sub-Investigator: Elizabeth Rand, MD         
Sub-Investigator: David Piccoli, MD         
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Madeline Schulte    412-692-5811    madeline.schulte@chp.edu   
Contact: Kathy Bukauskas, RN    412-692-7703    kathryn.bukauskas@chp.edu   
Principal Investigator: Benjamin Shneider, MD         
Sub-Investigator: Robert Squires, Jr, MD         
Sub-Investigator: Veena Venkat, MD         
United States, Texas
Baylor College of Medicine Active, not recruiting
Houston,, Texas, United States, 77030
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Melissa Young    206-987-1037    melissa.young@seattlechildrens.org   
Principal Investigator: Karen Murray, MD         
Sub-Investigator: Simon Horslen, MD         
Sub-Investigator: Evelyn Shu, MD         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Kelsey Hunt    416-813-7654 ext 201594    kelsey.hunt@sickkids.ca   
Contact: Claudia Quammie    416-813-7654 ext 201594    claudia.quammie@sickkids.ca   
Sub-Investigator: Vicky Ng, MD         
Principal Investigator: Binita Kamath, MD         
Sponsors and Collaborators
Investigators
Study Chair: Ronald Sokol, MD Children's Hospital Colorado
Study Director: Ed Doo, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: John Magee, MD University of Michigan Medical Center, Ann Arbor
  More Information

Additional Information:
No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00061828     History of Changes
Other Study ID Numbers: BARC - IND, U01-DK62456-01
Study First Received: June 5, 2003
Last Updated: September 15, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Biliary Atresia
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Congenital Abnormalities
Digestive System Abnormalities
Digestive System Diseases

ClinicalTrials.gov processed this record on November 20, 2014