Clinical trial · Observational
Biobank for Cholestatic Liver Diseases.
A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals
NCT03445585CI-TRIAL-00103399recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Primary Biliary Cirrhosis | — | UNRESOLVED | — |
| Primary Sclerosing Cholangitis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- Primary Sclerosing Cholangitis
- description
- Patients with a diagnosis of primary sclerosing cholangitis (PSC).
- label
- Primary Biliary Cirrhosis/Cholangitis
- description
- Patients with a diagnosis of primary biliary cirrhosis (PBC).
- label
- Control group 1
- description
- Patients who do not have PBC or PSC but do have another form of chronic liver disease.
- label
- Control group 2
- description
- Patients without liver disease.
Primary outcomes (1)
- measure
- Number of participants in the study.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: PSC * Patients diagnosed with PSC and who are between the age of 18 and 85 at time of enrollment in the study. * The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings, and compatible liver biopsies if available. * Patients with PSC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria. * Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation. PBC * Patients diagnosed with PBC and who are between the age of 18 and 85 at time of enrollment in the study. * The diagnosis of PBC will be based on standard PBC criteria including clinical and biochemical evidence of chronic cholestasis of at least six month duration, positive anti-mitochondrial antibodies in serum and compatible liver biopsies, if available. * Patients with PBC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria. * Women with PBC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation. Controls * Controls without history of PBC, PSC, or evidence of other chronic liver disease of either gender that participate in this study will be between the ages of 18 and 85. Liver Disease Controls * Patients without history of PBC or PSC but do have evidence of other chronic liver disease of either gender will be offered participation in this study if between the ages of 18 and 85. Exclusion Criteria (all subjects): * PBC or PSC patients with known and overlapping other chronic liver diseases * Patients unable to provide informed consent * Prisoners and institutionalized individuals Exclusion Criteria (for bile collection during ERCP) * PSC with orthotopic liver transplantation * History of Roux en Y
References
Publications (0)
Data not yet available
No reference posted for this study.