Screening for Chronic Liver Diseases in General Population

NCT06366425 | Recruiting DMC

• 1 other identifier: RECHMPL23_0272
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care.

Conditions

Fibrosis, Liver

Keywords

Non-alcoholic fatty liver disease (NAFLD); Hepatocellular carcinoma (HCC); Chronic liver diseases; Linkage to care; Fibrosis research; Non-invasive diagnosis; FIB-4; Fibroscan

Outcome Measures

Primary Outcomes (2)

• Evaluation of the liver fibrosis screening acceptability (FIB-4)

  percentage of patients who agreed to a FIB-4 blood test among all included patients offered screening.

  During the inclusion assessment at day 1 (Visit 0)

• Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan)

  percentage of patients who agreed to a FIB-4 blood test FIB-4 followed by Fibroscan (if FIB-4 score\>1.3) among all included patients offered screening.

  During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)

Secondary Outcomes (6)

• Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>1.3

  During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)

• Prevalence of excessive consumption of alcohol

  During the inclusion assessment at day 1 (Visit 0)

• Prevalence of a history or drug use

  During the inclusion assessment at day 1 (Visit 0)

• The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders)

  During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)

• prevalence of viral hepatitis

  During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)

Study Arms (1)

Population with a chronic liver disease risk factor

OTHER

Patient aged ≥ 40 years, with no known liver disease, consulting a general practitioner and having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of a metabolic syndrome, diabetes or a risk factor for viral hepatitis B/D or C.

Diagnostic Test: Blood sample then fibroscan

Interventions

Blood sample then fibroscan DIAGNOSTIC_TEST

The patient takes a blood test if none less than 6 months old is available, including a complete blood count (CBC) and a hepatic check. The FIB-4 score will be calculated from this blood test. If the result of the FIB-4 test is greater than 1.3 the person will be contacted by the SELHV (Service Expert de Lutte contre les Hépatites Virales) of the University Hospital of Montpellier in order to schedule, if she wishes, a second non-invasive screening examination of liver fibrosis by Fibroscan.

Population with a chronic liver disease risk factor

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years
• Without known liver pathologies
• Having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of metabolic syndrome, diabetes or a risk factor for viral hepatitis B, D or C.

You may not qualify if:

• Fibroscan already performed in the last 12 months
• Failure to collect express oral consent
• Patient not affiliated with or not benefiting from a national health insurance scheme
• Patient protected by law
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• On-call medical home (MMG) Clermont-Hérault: collaborator
• Medical office Montpeyroux: collaborator
• Medical office Clermont-Hérault: collaborator
• Medical office Aniane: collaborator

Study Sites (1)

CHU de Montpellier

Montpellier, 34295, France

RECRUITING

Related Publications (8)

• Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. 2008 Apr;134(4):960-74. doi: 10.1053/j.gastro.2008.01.034. Epub 2008 Jan 18.

  PMID: 18395077 BACKGROUND

• de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.

  PMID: 35120736 BACKGROUND

• Gines P, Castera L, Lammert F, Graupera I, Serra-Burriel M, Allen AM, Wong VW, Hartmann P, Thiele M, Caballeria L, de Knegt RJ, Grgurevic I, Augustin S, Tsochatzis EA, Schattenberg JM, Guha IN, Martini A, Morillas RM, Garcia-Retortillo M, de Koning HJ, Fabrellas N, Pich J, Ma AT, Diaz MA, Roulot D, Newsome PN, Manns M, Kamath PS, Krag A; LiverScreen Consortium Investigators. Population screening for liver fibrosis: Toward early diagnosis and intervention for chronic liver diseases. Hepatology. 2022 Jan;75(1):219-228. doi: 10.1002/hep.32163. Epub 2021 Dec 10.

  PMID: 34537988 BACKGROUND

• Dam-Larsen S, Franzmann M, Andersen IB, Christoffersen P, Jensen LB, Sorensen TI, Becker U, Bendtsen F. Long term prognosis of fatty liver: risk of chronic liver disease and death. Gut. 2004 May;53(5):750-5. doi: 10.1136/gut.2003.019984.

  PMID: 15082596 BACKGROUND

• Teli MR, Day CP, Burt AD, Bennett MK, James OF. Determinants of progression to cirrhosis or fibrosis in pure alcoholic fatty liver. Lancet. 1995 Oct 14;346(8981):987-90. doi: 10.1016/s0140-6736(95)91685-7.

  PMID: 7475591 BACKGROUND

• Marshall AD, Micallef M, Erratt A, Telenta J, Treloar C, Everingham H, Jones SC, Bath N, How-Chow D, Byrne J, Harvey P, Dunlop A, Jauncey M, Read P, Collie T, Dore GJ, Grebely J. Liver disease knowledge and acceptability of non-invasive liver fibrosis assessment among people who inject drugs in the drug and alcohol setting: The LiveRLife Study. Int J Drug Policy. 2015 Oct;26(10):984-91. doi: 10.1016/j.drugpo.2015.07.002. Epub 2015 Jul 16.

  PMID: 26256938 BACKGROUND

• Mwamba-Kalambayi P, Etienne A, Chirpaz E, Gelu-Simeon M, Cuissard L, Deloumeaux J, et al. Étude comparative de la fréquence des hépatites B et C chez les personnes nouvellement diagnostiquées pour carcinome hépatocellulaire en France métropolitaine et dans les départements et régions d'outre-mer, 2015-2019. Bull Epidémiol Hebd. 2022;(3-4): 85-94.

  BACKGROUND

• Oberti F, Cailliez E, Hubert I et al. Dépistage de la fibrose hépatique en populations générale et de médecine générale (étude DEFIH). Gastroenterol Clin Biol 2006;30:A7.

  BACKGROUND

Related Links

• Recommandations pour le diagnostic et le suivi non-invasif des maladies chronique du foie, Association Française pour l'étude du foie.

MeSH Terms

Conditions

Liver Cirrhosis; Non-alcoholic Fatty Liver Disease; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Magdalena MESZAROS, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Magdalena MESZAROS, MD

CONTACT

04 67 33 02 57; m-meszaros@chu-montpellier.fr

Corinne ROTROU, CRA

CONTACT

r-rotrou@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 15, 2024
• Study Start: September 11, 2024
• Primary Completion: October 9, 2024
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

FR (1)