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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood, urine and stool biocollection

    Other intervention

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Control groupOther 1 intervention
Group B: Case groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Blood sample for biocollection

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).

Time frame
Baseline
2

Urinary sample for biocollection

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).

Time frame
Baseline
3

faecal sample for biocollection

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).

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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