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Cirrhoses, LiverProspEXPONCT07119957

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

A study testing Blood, urine and stool biocollection in people with Cirrhoses, Liver and Carcinoma Liver, run by University Hospital, Angers at 4 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cirrhoses, Liver, Carcinoma Liver
What is being tested?
Blood, urine and stool biocollection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
4 sitesFrance
Study dates
17 Dec 2025to Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

France4 sites, 4 recruiting

  • Angers University Hospital

    Angers, 49000

    Jérôme BOURSIER, Professor, +33 (0)2 41 35 64 28, JeBoursier@chu-angers.fr

    Jeanne FICHEZ, +33 (0)2 41 35 64 28, Jeanne.Fichez@chu-angers.fr

    Recruiting

  • Centre Eugène Marquis (Oncology center)

    Rennes, 35000

    Julien EDELINE, +33 (0)2 99 25 31 96, j.edeline@rennes.unicancer.fr

    Not yet recruiting

  • Rennes University Hospital, Hepatogastroenteroly Department

    Rennes, 35000

    Edouard BARDOU-JACQUET, +33 (0)2 99 28 42 98, edouard.bardou.jacquet@chu-rennes.fr

    Not yet recruiting

  • Tours University Hospital, HepatoGastroenterology Department

    Tours, 37170

    Laure ELKRIEF, +33 (0)2 47 47 59 65, L.ELKRIEF@chu-tours.fr

    Not yet recruiting

Other trials in France

About this study

Official title: ProspEXPO : PROSPective 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.

Read the 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.

Being tested
Blood, urine and stool biocollection
Keywords
Liver Cirrhosis, HepatoCellular Carcinoma (HCC), Exposome
Medical subject headings
Carcinoma, Hepatocellular, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood, urine and stool biocollectionOther

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

Study groups in NCT07119957
Study groupRoleWhat they receive
Control groupOtherGroup of patients with MASLD and/or ALD at cirrhosis stage, without HCC
Receives: Other: Blood, urine and stool biocollection
Case groupOtherGroup of patients with MASLD and/or ALD at cirrhosis stage and complicated by HCC
Receives: Other: Blood, urine and stool biocollection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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).

    Measured: 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).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2025
  2. Study start17 Dec 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07119957
Sponsor's protocol ID
49RC25_0139
Other IDs
2025-A00678-41
Acronym
ProspEXPO
Status last verified
Jun 2026
First submitted
9 Jul 2025
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15915461

  • 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.

    PubMed 36765616

  • 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.

    PubMed 30367459

  • 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.

    PubMed 37776622

  • 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.

    PubMed 31028350

  • 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.

    PubMed 37199193

  • 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.

    PubMed 29628281

  • 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.

    PubMed 35793659

  • 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.

    PubMed 37170239

  • 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.

    PubMed 36626630

  • 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.

    PubMed 37364790

  • 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.

    PubMed 27773614

  • 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.

    PubMed 36208844

Questions about this trial

What is this clinical trial studying?

A study testing Blood, urine and stool biocollection in people with Cirrhoses, Liver and Carcinoma Liver, run by University Hospital, Angers at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jérôme BOURSIER, Professor (+33 (0)2 41 35 64 28, JeBoursier@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood sample for biocollection (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07119957, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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