Clinical trial · Interventional
Patients With Primary Biliary Cholangitis
Utility of a Reflex Test (ALP/GGT-AMA/ANA) for the Early Diagnosis of Primary Biliary Cholangitis in an Epidemiologically At-risk Patient Population
- 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)
Primary biliary cholangitis (PBC) is a chronic autoimmune disease characterized by progressive destruction of the small intrahepatic bile ducts, leading to cholestasis and potential progression to cirrhosis. Prognosis is favorable when diagnosed and treated early, while diagnostic delay is common. Diagnosis is based on elevated ALP and the presence of autoantibodies (AMA/ANA), but the disease is often asymptomatic and detected late.It predominantly affects women aged 40-60 years, and evidence suggests underdiagnosis, highlighting the need for screening strategies in at-risk populations.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Liver | — | UNRESOLVED | — |
| Intrahepatic Bile Duct Cancer | — | UNRESOLVED | — |
| Primary Biliary Cholangitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reflex AMA and ANA testing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Enrolled patients undergoing ALP/GGT reflex test with AMA/ANA follow-up if abnormal
- description
- Participants undergo routine measurement of alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT) on pre-hospitalization blood samples, followed by reflex testing for anti-mitochondrial antibodies (AMA) and anti-nuclear antibodies (ANA) in case of abnormal liver enzyme levels.
- interventionNames
- Procedure: Reflex AMA and ANA testing
Primary outcomes (1)
- measure
- Percentage of patients diagnosed with primary biliary cholangitis identified through a reflex testing algorithm (ALP/GGT → AMA/ANA)
- timeFrame
- 2-10 months
- description
- Proportion of women with elevated alkaline phosphatase (ALP) levels undergoing reflex testing (automatic measurement of AMA and ANA) who receive a diagnosis of primary biliary cholangitis according to standard clinical criteria. Results will be reported as a percentage of the total number of patients undergoing reflex testing.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female sex, * age ≥ 40 years, * patients attending the pre-hospitalization service for planned admission requiring the measurement of alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT or gamma-GT) as part of routine clinical practice; * the patient is able to understand the study information and provide informed consent. Exclusion Criteria: * Previous diagnosis of Primary Biliary Cholangitis (PBC) or other liver disease, * patients unable to understand the study information and for whom informed consent cannot be obtained, * patients with known conditions associated with elevated ALP: pregnancy, extrahepatic biliary obstruction (e.g., choledocholithiasis, biliary or pancreatic neoplasms), hepatic neoplasms or metastases, Paget's disease, bone neoplasms or metastases, hyperparathyroidism.
References
Publications (0)
Data not yet available