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

NCT07119957 | Not Yet Recruiting

• 2 other identifiers: 49RC25_01392025-A00678-41
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Cirrhoses, Liver; Carcinoma Liver

Keywords

Liver Cirrhosis; HepatoCellular Carcinoma (HCC); Exposome

Outcome Measures

Primary Outcomes (3)

• 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).

  Baseline

• 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).

  Baseline

• 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).

  Baseline

Study Arms (2)

Control group

OTHER

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

Other: Blood, urine and stool biocollection

Case group

OTHER

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

Other: Blood, urine and stool biocollection

Interventions

Blood, urine and stool biocollection OTHER

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

Case group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Causes of chronic liver disease other than MASLD, ALD, or MetALD
• For the "Control" group: history of hepatocellular carcinoma
• Pregnant, breast-feeding or parturient women
• Persons deprived of liberty by judicial or administrative decision

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (4)

Angers University Hospital

Angers, 49000, France

Location

Centre Eugène Marquis (Oncology center)

Rennes, 35000, France

Location

Rennes University Hospital, Hepatogastroenteroly Department

Rennes, 35000, France

Location

Tours University Hospital, HepatoGastroenterology Department

Tours, 37170, France

Location

Related Publications (13)

• Kleiner 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 BACKGROUND

• Tron 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 BACKGROUND

• Tron 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 BACKGROUND

• David 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 BACKGROUND

• Anstee 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 BACKGROUND

• Singal 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.

  PMID: 37199193 BACKGROUND

• European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.

  PMID: 29628281 BACKGROUND

• Huang DQ, Singal AG, Kono Y, Tan DJH, El-Serag HB, Loomba R. Changing global epidemiology of liver cancer from 2010 to 2019: NASH is the fastest growing cause of liver cancer. Cell Metab. 2022 Jul 5;34(7):969-977.e2. doi: 10.1016/j.cmet.2022.05.003. Epub 2022 Jun 3.

  PMID: 35793659 BACKGROUND

• Niu X, Zhu L, Xu Y, Zhang M, Hao Y, Ma L, Li Y, Xing H. Global prevalence, incidence, and outcomes of alcohol related liver diseases: a systematic review and meta-analysis. BMC Public Health. 2023 May 11;23(1):859. doi: 10.1186/s12889-023-15749-x.

  PMID: 37170239 BACKGROUND

• Younossi ZM, Golabi P, Paik JM, Henry A, Van Dongen C, Henry L. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology. 2023 Apr 1;77(4):1335-1347. doi: 10.1097/HEP.0000000000000004. Epub 2023 Jan 3.

  PMID: 36626630 BACKGROUND

• Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol. 2023 Dec;79(6):1542-1556. doi: 10.1016/j.jhep.2023.06.003. Epub 2023 Jun 24.

  PMID: 37364790 BACKGROUND

• Goutte N, Sogni P, Bendersky N, Barbare JC, Falissard B, Farges O. Geographical variations in incidence, management and survival of hepatocellular carcinoma in a Western country. J Hepatol. 2017 Mar;66(3):537-544. doi: 10.1016/j.jhep.2016.10.015. Epub 2016 Oct 20.

  PMID: 27773614 BACKGROUND

• Rumgay H, Arnold M, Ferlay J, Lesi O, Cabasag CJ, Vignat J, Laversanne M, McGlynn KA, Soerjomataram I. Global burden of primary liver cancer in 2020 and predictions to 2040. J Hepatol. 2022 Dec;77(6):1598-1606. doi: 10.1016/j.jhep.2022.08.021. Epub 2022 Oct 5.

  PMID: 36208844 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis

Interventions

Blood Specimen Collection; Urination

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Jérôme BOURSIER, Professor

  Angers University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérôme BOURSIER, Professor

CONTACT

+33 (0)2 41 35 64 28; JeBoursier@chu-angers.fr

Matthieu LE LAY, Master

CONTACT

+33 (0)2 41 35 58 91; matthieu.lelay@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)