Recall of a Cohort of Subjects in the Mediterranean Area. Monitoring of Liver Diseases (NUTRIHEP 3).
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
Dr. Rossella Donghia
Principal Investigator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
