Patients With Primary Biliary Cholangitis

NCT07573514 | Active Not Recruiting

• 1 other identifier: 27143
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Primary Biliary Cholangitis; Intrahepatic Bile Duct Cancer; Cancer Liver

Keywords

Alkaline Phosphatase; Serum Level Abnormal; Anti-mitochondrial antibodies; Specific ANA autoantibodies

Outcome Measures

Primary Outcomes (1)

• Percentage of patients diagnosed with primary biliary cholangitis identified through a reflex testing algorithm (ALP/GGT → AMA/ANA)

  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.

  2-10 months

Study Arms (1)

Enrolled patients undergoing ALP/GGT reflex test with AMA/ANA follow-up if abnormal

EXPERIMENTAL

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.

Procedure: Reflex AMA and ANA testing

Interventions

Reflex AMA and ANA testing PROCEDURE

Measurement of alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT) on routine pre-hospitalization blood samples, with reflex testing for anti-mitochondrial antibodies (AMA) and anti-nuclear antibodies (ANA) in case of abnormal results.

Enrolled patients undergoing ALP/GGT reflex test with AMA/ANA follow-up if abnormal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli,

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Francesca Romana Ponziani

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 7, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

IT (1)