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

University Hospital, Angers

Status: Not yet enrolling

Conditions: Carcinoma Liver; Cirrhoses, Liver

Treatments: Other: Blood, urine and stool biocollection

Study type: Interventional

Funder types: Other

Identifiers

NCT07119957

2025-A00678-41 (Other Identifier)

49RC25_0139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Control group

Other group

Description:

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

Treatment:

Other: Blood, urine and stool biocollection

Case group

Other group

Description:

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

Treatment:

Other: Blood, urine and stool biocollection