Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345553
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2006-06-27
Brief Title:
Biliary Atresia Study in Infants and Children
Sponsor:
Arbor Research Collaborative for Health
Organization:
Arbor Research Collaborative for Health
Study Overview
Official Title:
Biliary Atresia Study in Infants and Children BASIC
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:
BASIC
Brief Summary:
Little is known about the factors that cause biliary atresia nor the factors that influence disease progression 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 aims To identify the gene or genes implicated in the etiology of BA To identify polymorphisms that may be important in disease progression such as HLA polymorphisms To characterize the natural history of the older non-transplanted child with BA
Detailed Description:
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 Childhood Liver Disease Research Network ChiLDReN a National Institute of Diabetes Digestive and Kidney Diseases NIDDK funded network
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 Childhood Liver Disease Research Network ChiLDReN a National Institute of Diabetes Digestive and Kidney Diseases NIDDK funded network
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 |
|---|---|---|---|
| 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 |
| U01DK062436 | NIH | None | httpsreporternihgovquickSearchU01DK062436 |