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NCT Number: NCT07119957

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angers University Hospital, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood, urine and stool biocollection

Other

Collection of blood, urine and stool sampling in order to build up a biocollection

Primary outcomes

  1. Blood sample for biocollection

    Time frame: 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).

  2. Urinary sample for biocollection

    Time frame: 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).

  3. faecal sample for biocollection

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme BOURSIER, Professor

CONTACT

[email protected]

+33 (0)2 41 35 64 28

Matthieu LE LAY, Master

CONTACT

[email protected]

+33 (0)2 41 35 58 91

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: ProspEXPO

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 13, 2025
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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