Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061828
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2003-06-05
Brief Title:
A Prospective Database of Infants With Cholestasis
Sponsor:
Arbor Research Collaborative for Health
Organization:
Arbor Research Collaborative for Health
Study Overview
Official Title:
Childhood Liver Disease Research Network ChiLDReN A Prospective Database of Infants With Cholestasis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROBE
Brief Summary:
Biliary atresia idiopathic neonatal hepatitis and specific genetic cholestatic conditions are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period The long term goal of the Childhood Liver Disease Research Network ChiLDReN is to establish a database of clinical information and plasma serum and tissue samples from cholestatic children to facilitate research and to perform clinical epidemiological and therapeutic trials in these important pediatric liver diseases
Detailed Description:
This is a multi-center project to establish a prospective database of clinical information and a repository of blood and tissue samples from children with diagnoses of neonatal liver diseases such as biliary atresia BA idiopathic neonatal hepatitis INH and specific neonatal presentations of genetic cholestatic disorders in order to perform research in these important liver problems Children will be screened and enrolled at presentation at the participating pediatric liver sites Participants diagnosed with BA will be followed intensively for the first year at 18 months of age and then annually up to 20 years of age or liver transplantation Other participants diagnosed with cholestasis will be followed on the same schedule if there is complete clinical and biochemical resolution of their underlying liver disease off all therapy there will be one follow up visit within one year preferably scheduled at the time of the next planned follow up visit or at 12 months of age whichever is later for data collection and to obtain blood samples The development of a serum and tissue bank of specimens from children with various neonatal cholestatic disorders will be an invaluable tool for current and future investigations into the etiology and pathogenesis of hepatobiliary injury in the infant
Detailed clinical data laboratory investigations liver and biliary specimens and long-term follow-up of outcomes are part of the normal standard of care with respect to the diagnosis and treatment of the subjects with liver problems This research involves the collection of diagnostic clinical and outcome data concerning the subject which is kept without identification coded in a national research database of infants with liver disease Samples of blood will be obtained for later research analysis whenever possible at the time of clinically indicated blood draws or when there is IV access for a clinical procedure When liver biopsy specimens are obtained for diagnostic purposes any liver biopsy specimen in excess of that needed for diagnostic use will be sent to the tissue repository When a portoenterostomy or liver transplant occurs sections of the liver and biliary remnant removed in the course of surgery and in excess of that needed for diagnostic use will be sent for the repository These specimens will be used in investigations into the mechanisms and causes of the liver damage that occur in the participants condition All data from this study will be kept in a secure research database at the Scientific Data Coordinating Center SDCC and transferred to the National Institute of Diabetes and Digestive and Kidney Diseases NIDDK data repository after the study ends
Detailed clinical data laboratory investigations liver and biliary specimens and long-term follow-up of outcomes are part of the normal standard of care with respect to the diagnosis and treatment of the subjects with liver problems This research involves the collection of diagnostic clinical and outcome data concerning the subject which is kept without identification coded in a national research database of infants with liver disease Samples of blood will be obtained for later research analysis whenever possible at the time of clinically indicated blood draws or when there is IV access for a clinical procedure When liver biopsy specimens are obtained for diagnostic purposes any liver biopsy specimen in excess of that needed for diagnostic use will be sent to the tissue repository When a portoenterostomy or liver transplant occurs sections of the liver and biliary remnant removed in the course of surgery and in excess of that needed for diagnostic use will be sent for the repository These specimens will be used in investigations into the mechanisms and causes of the liver damage that occur in the participants condition All data from this study will be kept in a secure research database at the Scientific Data Coordinating Center SDCC and transferred to the National Institute of Diabetes and Digestive and Kidney Diseases NIDDK data repository after the study ends
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK062436 | NIH | None | httpsreporternihgovquickSearchU01DK062436 |
| U01DK103149 | NIH | None | None |
| U01DK103140 | NIH | None | None |
| U01DK103135 | NIH | None | None |
| U01DK084575 | NIH | None | None |
| U01DK084538 | NIH | None | None |
| U01DK084536 | NIH | None | None |
| U01DK062503 | NIH | None | None |
| U01DK062500 | NIH | None | None |
| U01DK062497 | NIH | None | None |
| U01DK062481 | NIH | None | None |
| U01DK062470 | NIH | None | None |
| U01DK062466 | NIH | None | None |
| U01DK062456 | NIH | None | None |
| U01DK062453 | NIH | None | None |
| U01DK062452 | NIH | None | None |
| U01DK062445 | NIH | None | None |