Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli,
Roma, 00168, Italy
NCT Number: NCT07573514
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Roma, 00168, Italy
Women will be consecutively enrolled during routine pre-hospitalization blood sampling for scheduled admissions at our University Hospital. In all participants, alkaline phosphatase (ALP) and gamma-glutamyl transpeptidase (GGT) will be measured on the same blood sample collected for standard clinical care.Patients with elevated ALP or GGT will undergo reflex testing for anti-mitochondrial antibodies (AMA) and anti-nuclear antibodies (ANA). Patients with positive AMA or ANA results will be informed and, if consenting, referred to a specialized gastroenterology and hepatology outpatient clinic for rare diseases.During this visit, based on reflex test results and clinical assessment, a diagnosis of primary biliary cholangitis (PBC) will be confirmed or further diagnostic evaluation will be performed if needed. Even if PBC is not confirmed, hepatology counseling and appropriate follow-up will be considered.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2-10 months
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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Utility of a Reflex Test (ALP/GGT-AMA/ANA) for the Early Diagnosis of Primary Biliary Cholangitis in an Epidemiologically At-risk Patient Population
Acronym: BILIFLEX
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