跳至主要内容
临床试验/NCT07119957
NCT07119957招募中不适用

ProspEXPO : PROSPective Study of the Associations Between Hepatocellular Carcinoma and Chemical and Psychosocial Environmental EXPOsome

University Hospital, Angers8 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年12月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
8
主要终点
Blood sample for biocollection

研究概览

简要总结

The aim of the study is to build up a bio-collection of biological samples from patients with cirrhosis. Further work using this bio-collection will permit to describe the influence of different exposome factors (nutrition, physical activity, socio-demographic conditions, tobacco, alcohol, pollutants) on the occurrence of the main type of liver cancer (called HCC).

Indeed, in the vast majority of cases, HCC develops within cirrhosis, and the factors that precipitate the progression of cirrhotic patients to HCC remain largely unknown.

详细描述

It has recently emerged that various elements of the exposome (pollutants, societal and psycho-social determinants, addictions, etc.) influence and modulate individual HCC risk. Indeed, by interacting with conventional risk factors (alcohol, unbalanced diet, metabolic factors, smoking, genetic predisposition), environmental factors (such as chemicals, air pollution, occupational exposures) are thought to contribute to oxidative stress, inflammation and the hepatic immune response, leading to a tumorigenic milieu in the liver. Very recently, we demonstrated a relationship between a perfluoroalkyl compound and the severity of steatosis in MASLD. Societal and psycho-social determinants also influence liver disease and HCC risk via dietary "dysbiosis" and "addictive behaviours". A population-based study conducted in France by the FRANCIM network, looking at the influence of socio-economic environment and disparities on cancer survival in 19 major solid tumors, showed that disadvantaged areas were associated with poorer survival, including for HCC. Taken together, these findings demonstrate the need for further research into the links between HCC and exposure to toxic chemicals, lifestyle, and the social and psychosocial environment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • Presence of metabolic and/or alcoholic steatotic liver disease, as defined by the new nomenclature (MASLD, ALD, or mixed MetALD)
  • Liver biopsy performed (less than 2 months ago) or planned as part of treatment for diagnosis of cirrhosis ("Control" group without HCC) or diagnosis of HCC on cirrhosis ("Case" group)
  • Patient affiliated to or benefiting from a social security scheme
  • Patient having signed an informed consent to participate in the study (bio-collection)

排除标准

  • Causes of chronic liver disease other than MASLD, ALD, or MetALD
  • Decompensation of cirrhosis in the two years prior to inclusion (ascites, hepatic encephalopathy, gastrointestinal variceal hemorrhage, liver failure, hepatorenal syndrome)
  • For the "Control" group: history of hepatocellular carcinoma
  • Pregnant, breast-feeding or parturient women
  • Persons deprived of liberty by judicial or administrative decision

研究组 & 干预措施

Control group

Other

Group of patients with MASLD and/or ALD at cirrhosis stage, without HCC

干预措施: Blood, urine and stool biocollection (Other)

Case group

Other

Group of patients with MASLD and/or ALD at cirrhosis stage and complicated by HCC

干预措施: Blood, urine and stool biocollection (Other)

结局指标

主要结局

Blood sample for biocollection

时间窗: Baseline

Blood samples will be collected in order to create a biocollection. Biological parameters will be defined only with future studies (no biological parameter scheduled for this study).

Urinary sample for biocollection

时间窗: Baseline

Urinary samples will be collected in order to create a biocollection. Biological parameters will be defined only with future studies (no biological parameter scheduled for this study).

faecal sample for biocollection

时间窗: Baseline

Faecal samples will be collected in order to create a biocollection. Biological parameters will be defined only with future studies (no biological parameter scheduled for this study).

次要结局

未报告次要终点

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (8)

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