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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07119957
Acronym
ProspEXPO
Enrollment
300
Registered
2025-08-13
Start date
2025-12-17
Completion date
2029-03-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma Liver, Cirrhoses, Liver

Keywords

Liver Cirrhosis, HepatoCellular Carcinoma (HCC), Exposome

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.

Interventions

OTHERBlood, urine and stool biocollection

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

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood sample for biocollectionBaselineBlood 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 biocollectionBaselineUrinary 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 biocollectionBaselineFaecal 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).

Countries

France

Contacts

CONTACTJérôme BOURSIER, Professor
JeBoursier@chu-angers.fr+33 (0)2 41 35 64 28
CONTACTMatthieu LE LAY, Master
matthieu.lelay@chu-angers.fr+33 (0)2 41 35 58 91
PRINCIPAL_INVESTIGATORJérôme BOURSIER, Professor

University Hospital, Angers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026