Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-01 @ 7:28 AM
Study NCT ID:
NCT07119957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ProspEXPO : Study of the Associations Between Hepatocellular Carcinoma and Chemical and Psychosocial Environmental EXPOsome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D014554', 'term': 'Urination'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood sample for biocollection', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Urinary sample for biocollection', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'faecal sample for biocollection', 'timeFrame': 'Baseline', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver Cirrhosis', 'HepatoCellular Carcinoma (HCC)', 'Exposome'], 'conditions': ['Cirrhoses, Liver', 'Carcinoma Liver']}, 'referencesModule': {'references': [{'pmid': '15915461', 'type': 'BACKGROUND', 'citation': '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': '36765616', 'type': 'BACKGROUND', 'citation': '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': '30367459', 'type': 'BACKGROUND', 'citation': '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': '37776622', 'type': 'BACKGROUND', 'citation': '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': '31028350', 'type': 'BACKGROUND', 'citation': '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': '37199193', 'type': 'BACKGROUND', 'citation': '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': '29628281', 'type': 'BACKGROUND', 'citation': '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': '35793659', 'type': 'BACKGROUND', 'citation': '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': '37170239', 'type': 'BACKGROUND', 'citation': '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': '36626630', 'type': 'BACKGROUND', 'citation': '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': '37364790', 'type': 'BACKGROUND', 'citation': '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': '27773614', 'type': 'BACKGROUND', 'citation': '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': '36208844', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nIndeed, 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of metabolic and/or alcoholic steatotic liver disease, as defined by the new nomenclature (MASLD, ALD, or mixed MetALD)\n* 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)\n* Patient affiliated to or benefiting from a social security scheme\n* Patient having signed an informed consent to participate in the study (bio-collection)\n\nExclusion Criteria:\n\n* Causes of chronic liver disease other than MASLD, ALD, or MetALD\n* Decompensation of cirrhosis in the two years prior to inclusion (ascites, hepatic encephalopathy, gastrointestinal variceal hemorrhage, liver failure, hepatorenal syndrome)\n* For the "Control" group: history of hepatocellular carcinoma\n* Pregnant, breast-feeding or parturient women\n* Persons deprived of liberty by judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT07119957', 'acronym': 'ProspEXPO', 'briefTitle': 'ProspEXPO : Study of the Associations Between Hepatocellular Carcinoma and Chemical and Psychosocial Environmental EXPOsome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'ProspEXPO : PROSPective Study of the Associations Between Hepatocellular Carcinoma and Chemical and Psychosocial Environmental EXPOsome', 'orgStudyIdInfo': {'id': '49RC25_0139'}, 'secondaryIdInfos': [{'id': '2025-A00678-41', 'type': 'OTHER', 'domain': 'ANSM (French Health Ministry)'}]}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Blood, urine and stool biocollection', 'type': 'OTHER', 'description': 'Collection of blood, urine and stool sampling in order to build up a biocollection', 'armGroupLabels': ['Case group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Jérôme BOURSIER, Professor', 'role': 'CONTACT', 'email': 'JeBoursier@chu-angers.fr', 'phone': '+33 (0)2 41 35 64 28'}, {'name': 'Jeanne FICHEZ', 'role': 'CONTACT', 'email': 'Jeanne.Fichez@chu-angers.fr', 'phone': '+33 (0)2 41 35 64 28'}, {'name': 'Jérôme BOURSIER, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'contacts': [{'name': 'Julien EDELINE', 'role': 'CONTACT', 'email': 'j.edeline@rennes.unicancer.fr', 'phone': '+33 (0)2 99 25 31 96'}], 'facility': 'Centre Eugène Marquis (Oncology center)', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'contacts': [{'name': 'Edouard BARDOU-JACQUET', 'role': 'CONTACT', 'email': 'edouard.bardou.jacquet@chu-rennes.fr', 'phone': '+33 (0)2 99 28 42 98'}], 'facility': 'Rennes University Hospital, Hepatogastroenteroly Department', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37170', 'city': 'Tours', 'country': 'France', 'contacts': [{'name': 'Laure ELKRIEF', 'role': 'CONTACT', 'email': 'L.ELKRIEF@chu-tours.fr', 'phone': '+33 (0)2 47 47 59 65'}], 'facility': 'Tours University Hospital, HepatoGastroenterology Department', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Jérôme BOURSIER, Professor', 'role': 'CONTACT', 'email': 'JeBoursier@chu-angers.fr', 'phone': '+33 (0)2 41 35 64 28'}, {'name': 'Matthieu LE LAY, Master', 'role': 'CONTACT', 'email': 'matthieu.lelay@chu-angers.fr', 'phone': '+33 (0)2 41 35 58 91'}], 'overallOfficials': [{'name': 'Jérôme BOURSIER, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Angers University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}