Biliary Atresia Research Consortium (PROBE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Recruiting
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: April 23, 2012
Last verified: April 2012
  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
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         
University of California Recruiting
San Francisco, California, United States, 94143
Contact: Camille Langlois    415-476-1756    langloisc@peds.ucsf.edu   
Contact: Shannon Fleck    415-476-1539    flecks@peds.ucsf.edu   
Principal Investigator: Philip Rosenthal, MD         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Sheryl Faut    720-777-4691    sheryl.faut@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         
United States, Georgia
Children's Healthcare of Atlanta (Emory University) Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sundari Sekar, MBBS, DGO    404-785-1467    sundari.sekar@choa.org   
Contact: jessica huamani    404-785-2200    jessica.huamani@choa.org   
Principal Investigator: Saul Karpen, MD, PhD         
United States, Illinois
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Contact: Sue Kelly, RN, BSN    773-868-8931    skelly@childrensmemorial.org   
Contact: Elizabeth Westfall    773-975-8523    ewestfall@childrensmemorial.org   
Principal Investigator: Peter Whitington, MD         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Beth RN Byam, RN    317-944-3774    ebyam@iupui.edu   
Contact: Ann Klipsch, RN    317-944-9605    aeye@iupui.edu   
Principal Investigator: Jean Molleston, MD         
United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Anitha Devadason    410-955-1736    cdevada2@jhmi.edu   
Contact: Kim Pfeifer, RN, BSN    410-614-8583    kfehily2@jhmi.edu   
Principal Investigator: Kathleen Schwarz, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St Louis, Missouri, United States, 63110
Contact: Kathleen Harris    314-747-5708    harris_k@kids.wustl.edu   
Contact: Stacy Postma    314-747-5931    postma_s@kids.wustl.edu   
Principal Investigator: Yumi Turmelle, MD         
United States, New York
Mount Sinai Medical Center Recruiting
New York City, New York, United States, 10029
Contact: Nacole Brown    212-659-8046    nacole.brown@mountsinai.org   
Principal Investigator: Nanda Kerkar Kerkar, MD         
United States, Ohio
Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jan Dietz    513-636-7266    jan.dietz@cchmc.org   
Contact: Kathleen Deal    513 636 7818    kathleen.deal@cchmc.org   
Principal Investigator: Jorge Bezerra, MD         
Sub-Investigator: John Bucuvalas, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessi MPH Erlichman, MPH    215-590-2525    erlichman@email.chop.edu   
Contact: Oyinkansola Kusemiju, MPH    267-426-0970    kusemijuo@email.chop.edu   
Principal Investigator: Kathleen Loomes, Loomes, MD         
Sub-Investigator: Elizabeth Rand, MD         
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Beverly Bernard, CRNP    412-692-5811    beverly.bernard@chp.edu   
Contact: Kathy Bukauskas, RN    412-692-7734    kathryn.bukauskas@chp.edu   
Principal Investigator: Benjamin Shneider, MD         
Sub-Investigator: Robert Squires, Jr, MD         
Sub-Investigator: David Perlmutter, 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         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Allison Chiu    416-813-7654 ext 1594    allison.chiu@sickkids.ca   
Contact: Ann Fu    416-813-7654 ext 1594    ann.fu@sickkids.ca   
Principal Investigator: Vicky Ng, 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: April 23, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 18, 2014