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The goal of this observational study is to achieve early diagnosis of Primary Biliary Cholangitis (PBC) in patients with positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP) in adults aged 18-80 years with positive AMA and normal ALP. The main question it aims to answer is:
• Are there any predictive factors for histological PBC in patients with positive AMA and normal ALP? Participants will undergo a liver biopsy and specific blood tests if eligible based on inclusion and exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case patients | Patientes aged 18-80 years, with positive AMA (≥1:40 titer) and persistently normal ALP |
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| Measure | Description | Time Frame |
|---|---|---|
| Scheuer's criteria | Liver biopsy samples | Just once, at enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Enhanced Liver Fibrosis (ELF) Score | Utilizes biomarkers such as hyaluronic acid, tissue inhibitor of metalloproteinase-1 (TIMP-1), and procollagen III amino-terminal peptide (PIIINP) | Just once, at enrollment |
| Fibroblast Growth Factor 19 (FGF-19) |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged 18-80 years with positive AMA and normal ALP
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
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Liver biopsy samples
Provides insights into bile acid regulation and metabolic liver function. Quantified using enzyme-linked immunosorbent assay (ELISA)
| Just once, at enrollment |
| Tumor Necrosis Factor-alpha (TNF-α) | Measured via high-sensitivity ELISA to assess inflammatory status | Just once, at enrollment |
| Cytokine Profiling (Interleukin-6, -12, -23) | Serum cytokine levels will be determined using multiplex immunoassays | Just once, at enrollment |
| Transforming Growth Factor-beta (TGF-β) | Quantified via ELISA to evaluate its role in fibrosis and immune regulation | Just once, at enrollment |
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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