Biliary Atresia Research Consortium (PROBE)
This study is currently recruiting participants.
Verified April 2012 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: April 23, 2012
Last verified: April 2012
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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 |
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
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 May 23, 2013