Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma Liver | — | UNRESOLVED | — |
| Cirrhoses, Liver | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood, urine and stool biocollection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Control group
- description
- Group of patients with MASLD and/or ALD at cirrhosis stage, without HCC
- interventionNames
- Other: Blood, urine and stool biocollection
- type
- OTHER
- label
- Case group
- description
- Group of patients with MASLD and/or ALD at cirrhosis stage and complicated by HCC
- interventionNames
- Other: Blood, urine and stool biocollection
Primary outcomes (3)
- measure
- Blood sample for biocollection
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 decisionReferences
Publications (13)
- RESULTKleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. doi: 10.1002/hep.20701. PMID 15915461
- RESULTTron L, Remontet L, Fauvernier M, Rachet B, Belot A, Launay L, Merville O, Molinie F, Dejardin O, Francim Group, Launoy G. Is the Social Gradient in Net Survival Observed in France the Result of Inequalities in Cancer-Specific Mortality or Inequalities in General Mortality? Cancers (Basel). 2023 Jan 20;15(3):659. doi: 10.3390/cancers15030659. PMID 36765616
- RESULTTron L, Belot A, Fauvernier M, Remontet L, Bossard N, Launay L, Bryere J, Monnereau A, Dejardin O, Launoy G; French Network of Cancer Registries (FRANCIM). Socioeconomic environment and disparities in cancer survival for 19 solid tumor sites: An analysis of the French Network of Cancer Registries (FRANCIM) data. Int J Cancer. 2019 Mar 15;144(6):1262-1274. doi: 10.1002/ijc.31951. Epub 2018 Dec 3. PMID 30367459
- RESULTDavid N, Antignac JP, Roux M, Marchand P, Michalak S, Oberti F, Fouchard I, Lannes A, Blanchet O, Cales P, Blanc EB, Boursier J, Canivet CM. Associations between perfluoroalkyl substances and the severity of non-alcoholic fatty liver disease. Environ Int. 2023 Oct;180:108235. doi: 10.1016/j.envint.2023.108235. Epub 2023 Sep 27. PMID 37776622
- RESULTAnstee QM, Reeves HL, Kotsiliti E, Govaere O, Heikenwalder M. From NASH to HCC: current concepts and future challenges. Nat Rev Gastroenterol Hepatol. 2019 Jul;16(7):411-428. doi: 10.1038/s41575-019-0145-7. PMID 31028350
- RESULTSingal AG, Llovet JM, Yarchoan M, Mehta N, Heimbach JK, Dawson LA, Jou JH, Kulik LM, Agopian VG, Marrero JA, Mendiratta-Lala M, Brown DB, Rilling WS, Goyal L, Wei AC, Taddei TH. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology. 2023 Dec 1;78(6):1922-1965. doi: 10.1097/HEP.0000000000000466. Epub 2023 May 22. No abstract available.