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Liver PathologyDEP-CBNCT06755632

Screening of Patients With Hepatic Fibrosis or Cirrhosis B and C

A study testing TROD (rapid diagnostic orientation test) and FibroScan® in people with Liver Pathology, run by Assistance Publique - Hôpitaux de Paris at 2 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

Regardless of its etiology (chronic hepatitis B or C, alcohol consumption, metabolic steatohepatitis, hemochromatosis, autoimmune liver disease), cirrhosis is a real public health issue. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Pathology
What is being tested?
TROD (rapid diagnostic orientation test) and FibroScan®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
2 sitesFrance
Study dates
19 Jun 2025to 19 Jun 2027
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

  • Age≥18 years
  • Collection of signed consent
  • Patients affiliated to a Social Security System

Who cannot join

  • Pregnancy or breastfeeding
  • Subjects under AME
  • Persons under court protection
  • Guardianship or curatorship,
  • Safeguard of justice
  • Persons under psychiatric care without their consent
Show all 9Show fewer
  • Persons admitted to a health or social institution for purposes other than research,
  • Patients of full age under legal protection (guardianship or curatorship)
  • Persons unable to express their consent.

Trial locations and contacts

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

Veronique GRANDO, MD-PhD contact

01 48 02 68 03 ext. +0033

veronique.grando@aphp.fr

France2 sites, 1 recruiting

  • Avicenne Hospital

    Bobigny, 93000

    Véronique GRANDO, MD-PHD, 01 48 02 68 03 ext. +0033, veronique.grando@aphp.fr

    Recruiting

  • Hepatology department -Hospital Avicenne

    Bobigny, 93100

    Withdrawn

Other trials in France

About this study

Official title: Out-of-hospital Screening of Patients With Significant Hepatic Fibrosis or Cirrhosis and Viral Hepatitis B and C

Regardless of its etiology (chronic hepatitis B or C, alcohol consumption, metabolic steatohepatitis, hemochromatosis, autoimmune liver disease), cirrhosis is a real public health issue. Cirrhosis is a chronic disease and can get complicated by liver cancer, digestive hemorrhage, or liver failure, which are responsible for morbidity and mortality.

In France, cirrhosis prevalence is estimated at 700,000 patients and induce 16,000 deaths per year (10,000 liver cancer and 6,000 liver decompensation). In Ile-de-France area, cirrhosis prevalence is estimated at 130,000 cases, a lot of them are in Seine Saint Denis department due to precariousness.

Read more

Hepatitis C virus can now be cured and hepatitis B treatment can suspend hepatitis B replication. All these treatments reduce liver complications but even after virological cure, cirrhosis requires dedicated long term management as well as alcoholic liver disease and metabolic steatohepatitis at cirrhosis stage.

Periodic screening for complications and specific measures were defined by french HAS in 2007 (medication intake, dietary management and specific vaccinations), especially the performance of a semi-annual liver ultrasound for hepatocellular carcinoma (HCC) screening.

Then, it seems essential to screen for patients with viral hepatitis and extensive fibrosis or cirrhosis in our department to achieve active and individualized management of this chronic liver disease, to reduce long term morbidity and mortality.

The main aim of the study is to evaluate the prevalence of advanced liver fibrosis and viral infections B and C in the general population of Seine Saint Denis, using a dual screening method of TROD (rapid diagnostic orientation test) and FibroScan®, combined with a care pathway

Read the detailed description

Targeted population

The targeted population will be users of one municipal health center visiting the municipal health center on a given day We will propose a screening for liver fibrosis using Fibroscan mini® and will propose rapid diagnostic orientation tests (TROD) for HCV and HBV viral infection, by a traveling physician Expérimental scheme

Proposal by the caregiver to each patient at the center :

  • Fibroscan®
  • TROD VHC / VHB IF Fibroscan ≥ 9.6 KPa or positive HCV TROD or HBsAg positive THEN Suggested appointment Avicenne hospital hepatology consultation or Jean Verdier hepatology consultation
Conditions
Liver Pathology
Being tested
TROD (rapid diagnostic orientation test) and FibroScan®
Keywords
Cirrhosis, Liver, Hepatic Cirrhosis, Liver Fibrosis, Fibrosis
Medical subject headings
Liver Cirrhosis, Fibrosis

What participants receive

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

  • TROD (rapid diagnostic orientation test) and FibroScan®Diagnostic test

    Fast-track appointment at the hepatology consultation at Avicenne Hospital (Bobigny) or the hepatology consultation at Jean Verdier Hospital (Bondy) for any patient :

    • with Fibroscan® ≥ 9.6 KPa or
    • positive hepatitis C serology or
    • HBsAg positive
Study groups in NCT06755632
Study groupRoleWhat they receive
Patients of a municipal health center who visit the municipal health center on a given day.ExperimentalNot described
Receives: Diagnostic Test: TROD (rapid diagnostic orientation test) and FibroScan®

What is being measured

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

  1. Prevalence of significant hepatic fibrosis in the general population of Seine Saint Denis

    Measured: Two year of inclusion period

Secondary outcomes (7)

  1. Chronic hepatitis B prevalence

    Measured: Two year of inclusion period

  2. Chronic hepatitis C prevalence

    Measured: Two year of inclusion period

  3. Proportion of eligible patients for management of viral hepatitis B and C

    Proportion of eligible patients for management of viral hepatitis B and C

    Measured: Two year of inclusion period

  4. Prevalence of other causes of chronic liver disease (alcohol and NASH)

    Measured: Two year of inclusion period

  5. Proportion of patients managed in hepatology department after screening for significant fibrosis

    Measured: Two year of inclusion period

  6. Prevalence of confirmed significant liver fibrosis in patients referred to hepatology consultation

    This criterion will be assessed based on follow-up FibroScan results, non-invasive fibrosis blood tests, and/or liver biopsy when indicated, in accordance with current hepatology guidelines.

    Measured: Two years of inclusion period

  7. Proportion of patients with ultrasound signs of cirrhosis and hepatocellular carcinoma among patients referred to hepatology consultation (managed according to current hepatology guidelines).

    This criterion will be assessed based on abdominal ultrasound findings according to current hepatology guidelines.

    Measured: Two years of inclusion period

Timeline

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

  1. First posted1 Jan 2025
  2. Study start19 Jun 2025
  3. Primary completion19 Jun 2027 (estimated)
  4. Study completion19 Jun 2027 (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
Not applicable
Intervention model
Single group
Model description
screening for liver fibrosis using Fibroscan mini® and will propose rapid diagnostic orientation tests (TROD) for HCV and HBV viral infection, by a traveling physician
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06755632
Sponsor's protocol ID
APHP240250
Acronym
DEP-CB
Status last verified
Jul 2026
First submitted
24 Dec 2024
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26256938

  • Matthews K, MacGilchrist A, Coulter-Smith M, Jones J, Cetnarskyj R. A nurse-led FibroScan(R) outreach clinic encourages socially deprived heavy drinkers to engage with liver services. J Clin Nurs. 2019 Feb;28(3-4):650-662. doi: 10.1111/jocn.14660. Epub 2018 Sep 24.

    PubMed 30182502

  • Chevaliez S, Pawlotsky JM. New virological tools for screening, diagnosis and monitoring of hepatitis B and C in resource-limited settings. J Hepatol. 2018 Oct;69(4):916-926. doi: 10.1016/j.jhep.2018.05.017. Epub 2018 May 23.

    PubMed 29800630

  • Debette-Gratien M, Francois S, Chevalier C, Alain S, Carrier P, Rigaud C, Abraham B, Burgevin AL, Courat L, Debenes B, Koffi J, Caux-Nussbaum E, Zattoni-Leroy J, Feuillet-Sow G, Dumont Q, Nubukpo P, Loustaud-Ratti V. Towards hepatitis C elimination in France: Scanvir, an effective model to test and treat drug users on dedicated days. J Viral Hepat. 2023 Apr;30(4):355-361. doi: 10.1111/jvh.13798. Epub 2023 Jan 11.

    PubMed 36597183

  • Ganne-Carrie N, Layese R, Bourcier V, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, de Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Riachi G, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Attali P, Bacq Y, Wartelle C, Dao T, Benhamou Y, Pilette C, Silvain C, Christidis C, Capron D, Bernard-Chabert B, Zucman D, Di Martino V, Trinchet JC, Nahon P, Roudot-Thoraval F; ANRS CO12 CirVir Study Group. Nomogram for individualized prediction of hepatocellular carcinoma occurrence in hepatitis C virus cirrhosis (ANRS CO12 CirVir). Hepatology. 2016 Oct;64(4):1136-47. doi: 10.1002/hep.28702. Epub 2016 Aug 4.

    PubMed 27348075

  • European Association for the Study of the Liver. EASL Clinical Practice Guidelines on non-invasive tests for evaluation of liver disease severity and prognosis - 2021 update. J Hepatol. 2021 Sep;75(3):659-689. doi: 10.1016/j.jhep.2021.05.025. Epub 2021 Jun 21.

    PubMed 34166721

Questions about this trial

What is this clinical trial studying?

A study testing TROD (rapid diagnostic orientation test) and FibroScan® in people with Liver Pathology, run by Assistance Publique - Hôpitaux de Paris at 2 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 3 inclusion and 9 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 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Veronique GRANDO, MD-PhD (01 48 02 68 03 ext. +0033, veronique.grando@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of significant hepatic fibrosis in the general population of Seine Saint Denis (time frame: Two year of inclusion period). 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 NCT06755632, which also lists 6 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 23 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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