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临床试验/NCT06931925
NCT06931925尚未招募不适用

Recall of a Cohort of Subjects in the Mediterranean Area. Monitoring of Liver Diseases (NUTRIHEP 3).

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis0 个研究点目标入组 2,300 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,300
主要终点
Elaboration of Poligenic Risk

研究概览

简要总结

Liver diseases represent a significant public health problem, with a high prevalence and a growing incidence worldwide, and a significant impact on global morbidity and mortality, causing approximately 2 million deaths annually.

Deaths are largely attributable to complications of cirrhosis and hepatocellular carcinoma.

The most common causes of cirrhosis worldwide are related to viral hepatitis, alcohol, and non-alcoholic fatty liver disease caused by poor dietary habits.

Regarding the hepatitis B virus (HBV), the vaccination program, together with the improvement of socioeconomic conditions and greater public awareness, have progressively reduced the incidence and prevalence of this viral disease. Chronic hepatitis related to the hepatitis C virus (HCV), after an increase in the 1980s and 1990s, is showing a decreasing trend, particularly among younger age groups. While other studies have focused on liver diseases of metabolic origin, the most recent epidemiological data concerning the Italian population were collected in the late 1990s. Since a decade has now passed, it was thought that it might be interesting to collect new data on the prevalence pattern of liver diseases, especially in southern Italy, particularly in a municipality equally geographically distant from both the coast and the inland. Therefore, this observational study aims to analyze the evolution of liver diseases through the recall of a cohort of patients already identified in the Mediterranean area. The cohort is composed of individuals residing in the municipality of Putignano (BA) who have already undergone evaluation of liver function, comorbidities and dietary habits, in addition to adding genetic information through genome-wide association (GWAS) analyses, useful for identifying associations between genetic variants and specific phenotypic characteristics

详细描述

Liver diseases represent a significant public health problem, with a high prevalence and a growing incidence worldwide, and a significant impact on global morbidity and mortality, causing approximately 2 million deaths annually. Deaths are largely attributable to complications of cirrhosis and hepatocellular carcinoma. The most common causes of cirrhosis worldwide are related to viral hepatitis, alcohol, and non-alcoholic fatty liver disease caused by poor dietary habits. Hepatotropic viruses are the etiological factor in most cases of acute hepatitis, but drug-induced liver injury increasingly represents a significant percentage of cases.

In Italy, the incidence of liver diseases has been the subject of studies in recent years. Based on these data, Italy has been identified as a "hyper-endemic" region where both viral and metabolic etiologies are responsible for a high prevalence and incidence of chronic liver diseases. Furthermore, a progressive increase in the incidence of viral hepatitis from Northern to Southern Italy has been observed. In recent decades, the etiology of these diseases has been undergoing a significant change.

Regarding the hepatitis B virus (HBV), the vaccination program, along with improved socioeconomic conditions and greater population awareness, have progressively reduced the incidence and prevalence of this viral disease. Chronic hepatitis related to the hepatitis C virus (HCV), after an increase in the 1980s and 1990s, is now showing a decreasing trend, particularly among younger age groups. While other studies have focused on liver diseases of metabolic origin (ASLD, MetALD, ALD, etc.), which are indicated as one of the most common causes of liver disease worldwide and in Italy, the most recent epidemiological data concerning the Italian population were collected in the late 1990s. As a decade has now passed, it was thought that it might be interesting to collect new data on the prevalence pattern of liver diseases, especially in Southern Italy, particularly in a municipality geographically equidistant from both the coast and the hinterland.

Therefore, this observational study aims to analyze the evolution of liver diseases by recalling a cohort of patients already identified in the Mediterranean area. The cohort consists of individuals residing in the municipality of Putignano (BA) who have already undergone evaluation of liver function, comorbidities, and dietary habits, in addition to adding genetic information through genome-wide association (GWAS) analysis, useful for identifying associations between genetic variants and specific phenotypic characteristics with the aim of discovering genetic correlations that can contribute to the molecular understanding of liver diseases and related comorbidities, using a representative population sample.

The analysis of the collected data aims to identify risk factors and predictive biomarkers of liver disease progression, with the goal of optimizing prevention and management strategies. The results will provide useful information to improve clinical surveillance and promote personalized interventions in individuals with liver diseases. The analyses will be conducted using advanced bioinformatics and statistical methodologies to ensure the robustness of the results.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •>18 Years
  • •Resident of Putignano (BA -Italy)

排除标准

  • •< 18 years

结局指标

主要结局

Elaboration of Poligenic Risk

时间窗: 36 months

Identification of SNP groups associated with liver disease to construct a polygenic risk score

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Rossella Donghia

Principal Investigator

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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