An interventional study of blood sampling and skin biopsy sampling in Biliary Atresia, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Active, not recruiting at 2 sites in France. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Basic science
Although considered a rare disease, Biliary Atresia (BA) is the leading cause of neonatal cholestasis and liver transplantation in children. Little is known about the molecular mechanisms that drive BA. The purpose of this study is to collect the fluid samples, explanted liver tissue samples and dermal biopsy samples to enable investigators to perform the genetic and molecular analyses that might point to the gene(s) and cellular pathway involved in etiology of BA disease.
Biliary atresia (BA) is a disease characterized by intra- and extra-hepatic bile duct obstruction diagnosed in the neonatal period. If left untreated, this obstruction leads to biliary cirrhosis and early death. Although considered a rare disease (between 1/15,000 and 1/20000 births), it is the leading cause of neonatal cholestasis and liver transplantation in children. The reasons for this obstruction are still poorly known and might involve several factors (immune, infectious and possible toxin effect). The accumulating evidence point to genetic factors involved, yet they are not of the classic monogenic or Mendelian types. The purpose of this study is to collect the fluid samples, explanted liver tissue samples and dermal biopsy samples to enable investigators to perform the genetic and molecular analyses that might point to the gene(s) and cellular pathway involved in etiology of BA disease.
77 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 43 interventional studies indexed under Biliary Atresia.
Browse Biliary Atresia studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
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Exclusion Criteria:
* Collection of blood samples from BA patients and their parents * Collection of explanted liver tissue and skin biopsy of BA patients
Other: blood sampling · Other: skin biopsy sampling · Other: explanted liver of BA patients sampling
collection of blood sample for preparation of DNA
preparation of primary cultures of dermal fibroblasts from skin biopsy sample
cryoconservation of liver tissue for molecular analyses
To identify the molecular mechanisms implicated in the etiology of BA
To identify gene(s) and cellular pathways affected in cells and liver tissue of BA patients: sequencing experiments
Time frame: 10 Years
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2021 (actual). Primary completion is estimated for Feb 2031, 119 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Aug 2026 → Feb 2031 and completion Feb 2032 → Feb 2031.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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