Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.

Study Overview
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Brief Summary
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The goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis C virus chronic infection in general population born before january 1st 1968 in Italy. The main questions it aims to answer are: what is the prevalence of hepatits C virus infection in general population born before January 1st, 1968? What rare the characteristics of these patients compared to the general population? What is the prevalence of patients tested HCV positive who are referred to the Hepatology Outpatient Clinic for further evaluation? What is the prevalence of patients with HCV infection detected during the study and treated with direct antiviral agents during follow up? Participants will be tested with a point of care screening test (Meridian, Bioscience) able to detect anti-HCV antibodies to detect the presence of antibodies against HCV.

Official Title
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Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.

Conditions
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Hepatitis C, Chronic, Hepatitis C, Hepatitis

Intervention / Treatment
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* Diagnostic Test: Meridan Bioscience Point of Care test against HCV antibodies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli Exclusion Criteria: Patients born after january 1st 1968 Known infection of hepatitis C virus Previous treatment against hepatitis C virus

Ages Eligible for Study
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Minimum Age: 54 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Meridan Bioscience Point of Care test against HCV antibodies|Point of care evaluation of antibodies against HCV obtaining a drop of capillary blood via puncture of the fingertip. If antibodies were detected, HCV RNA assay will be performed.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of antibodies against hepatitis C virus in cohort population | Evaluation of prevalence of antibodies against HCV in patients referred to any department of Policlinico Gemelli born before January 1st 1968 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of population |  | 24 months | 
| Prevalence of patients with a confirmed chronic HCV infection who are referred to Hepatology Outpatient clinic |  | 24 months | 
| Prevalence of patients with a confirmed chronic HCV infection who are treated with direct antiviral agents |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C virus