Biliary Atresia Study in Infants and Children (BASIC)
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| ClinicalTrials.gov Identifier: NCT00345553 |
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Recruitment Status :
Recruiting
First Posted : June 28, 2006
Last Update Posted : February 19, 2018
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| Condition or disease |
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| Biliary Atresia |
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 Biliary Atresia Research Clinical Research Consortium (BARC), an NIDDK-funded network.
| Study Type : | Observational |
| Estimated Enrollment : | 1265 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Biliary Atresia Study in Infants and Children (BASIC) |
| Study Start Date : | May 2006 |
| Estimated Primary Completion Date : | May 2019 |
| Estimated Study Completion Date : | May 2019 |
| Group/Cohort |
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1
Biliary atresia subjects who have their native liver
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2
Biliary atresia subjects who have had a liver transplant
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- To identify the gene or genes implicated in the etiology of BA [ Time Frame: Specimens for this aim are collected once during study, usually at baseline. ]
- To identify polymorphisms that may be important in disease progression such as HLA polymorphisms [ Time Frame: Specimens for this aim are collected once during study, usually at baseline. ]
- Define the natural history of the older, non-transplanted child with biliary atresia [ Time Frame: Observational information collected at entrance into study as well as at each yearly follow-up visit. ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 6 Months and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subjects 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).
- Subjects need to be greater than or equal to (with no upper age limit).
- Subject either have their native liver or have a confirmed liver transplantation.
- Parent, guardian or subject (if 18 years of age or older) is willing to provide informed consent and, when appropriate, the subject is willing to assent.
Exclusion Criteria:
- Enrollment in the PROBE study
- Inability to confirm original diagnostic evaluation of biliary atresia
- Inability or unwillingness of family or subject to participate in all scheduled visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345553
| Contact: Peg Hill-Callahan, BS, LSW | 734-369-9674 | peg.hill-callahan@arborresearch.org | |
| Contact: Joanne Lord, CCRC | 734-369-9965 | joanne.lord@arborresearch.org |
| United States, California | |
| Children's Hospital of 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: Sonia Michail, MD | |
| Sub-Investigator: Danny Thomas, MD | |
| University of California at San Francisco | Active, not recruiting |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Children's Hospital Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Michelle Hite 720-777-4690 michelle.hite@childrenscolorado.org | |
| Contact: Darci Anderson 720-777-9911 darci.anderson@childrenscolorado.org | |
| Sub-Investigator: Cara Mack, MD | |
| Sub-Investigator: Michael Narkewicz, MD | |
| Principal Investigator: Ronald Sokol, MD | |
| Sub-Investigator: Shikha Sundaram, MD | |
| United States, Georgia | |
| Children's Healthcare of Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| 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 | |
| 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: Mary Riordan, CCRP 312-227-4558 mriordan@luriechildrens.org | |
| Principal Investigator: Estella Alonso, MD | |
| Sub-Investigator: Lee Bass, MD | |
| United States, Indiana | |
| Riley Children's Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Ann Klipsch, RN 317-944-9605 aeye@iupui.edu | |
| Contact: Cindy Sawyers, RT 317-944-1421 clsawyer@iu.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 |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Mount Sinai Medical Center | Completed |
| New York, 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: Kelly Gindling 513-803-7482 kelly.gindling@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 215-590-2525 erlichman@email.chop.edu | |
| Contact: Sarah Wong 267-426-8412 wongsk@email.chop.edu | |
| Principal Investigator: Kathy Loomes, MD | |
| Sub-Investigator: Elizabeth Rand, MD | |
| Sub-Investigator: David Piccoli, MD | |
| Children's Hospital at Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Kathy Bukauskas 412-692-7703 kathryn.bukauskas@chp.edu | |
| Principal Investigator: Robert Squires, MD | |
| Sub-Investigator: Veena Venkat, MD | |
| Sub-Investigator: Jim Squires, MD | |
| Sub-Investigator: David Perlmutter, MD | |
| United States, Texas | |
| Texas Children's Hospital/Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Cynthia Tsai 832-822-3634 ct2@bcm.edu | |
| Contact: Laurel Cavallo 832-822-1053 Laurel.Cavallo@bcm.edu | |
| Sub-Investigator: Paula Hertel, MD | |
| Principal Investigator: Benjamin Shneider, MD | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84113 | |
| Contact: Ann Rutherford 801-585-9495 ann.rutherford@hsc.utah.edu | |
| Sub-Investigator: Stephen Guthery, MD | |
| United States, Washington | |
| Childern's Hospital & Regional Medical Center | 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 | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Vanessa Simoes 416-813-7654 ext 201594 Vanessa.simoes@sickkids.ca | |
| Contact: Elena Reydman 416-813-7654 elena.reydman@sickkids.ca | |
| Sub-Investigator: Vicki Ng, MD | |
| Principal Investigator: Binita Kamath, MD | |
| Study Chair: | Vicky Ng, MD | The Hospital for Sick Children, Toronto, ON, Canada | |
| Study Director: | Ed Doo, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |
| Principal Investigator: | John C Magee, MD | University of Michigan | |
| Principal Investigator: | Robert M Merion, MD | Arbor Research Collaborative for Health - Data Coordinating Center | |
| Study Director: | Averell Sherker, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Keywords provided by Arbor Research Collaborative for Health:
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Biliary Atresia Cholestasis |
Additional relevant MeSH terms:
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Biliary Atresia Bile Duct Diseases Biliary Tract Diseases |
Digestive System Diseases Digestive System Abnormalities Congenital Abnormalities |