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

Not Applicable

Not yet recruiting

• Conditions: Cirrhoses, Liver; Carcinoma Liver

• Registration Number: NCT07119957
• Lead Sponsor: University Hospital, Angers

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-07-09
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-09-01
• Primary Completion: 2028-09
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood sample for biocollection	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	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	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).

Trial Locations

Locations (4)

Angers University Hospital; 🇫🇷 Angers, France

Centre Eugène Marquis (Oncology center); 🇫🇷 Rennes, France

Rennes University Hospital, Hepatogastroenteroly Department; 🇫🇷 Rennes, France

Tours University Hospital, HepatoGastroenterology Department; 🇫🇷 Tours, France