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CompletedNCT02983968SAMHEPATUpdated Jun 12, 2026

Use of the French Healthcare Insurance Database

An observational study in Cirrhosis, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
75,868
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).

Read the detailed description

Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths). This cancer is closely associated with the presence of chronic liver underlying disease and early diagnosis following a systematic surveillance of cirrhotic patients could improve disease-free survival in patients declaring HCC. However, the risk-benefit ratio of such monitoring is discussed. Nevertheless, it is recommended in patients with liver cirrhosis, from which the prevalence is estimated between 0.3% and 0.6% in the French population. This debate can lead to a failure to comply with recommendations and promote a large variability in the management of the surveillance of HCC in patients with cirrhosis in practice. Data acquisition regarding the current situation in France is required.

The objective of this project is to use this database to document current practices concerning monitoring of incidents HCC in cirrhotic patients in France. A retrospective cohort study will be conducted on data from SNIIRAM recorded between 2007 and 2015. The primary analysis will focus on multivariate modelling of the deviation rate from the recommendations (advising the realisation of at least two echodoppler ultrasonographies yearly) with a competitive risk model, taking into account gender, social status, Charlson index, age at baseline, the alcoholic etiology of cirrhosis, type of facility and the yearly number of visits to a hepatologist during follow-up. It is estimated that more than 86,000 patients with a minimum follow-up of 3 years will be included in the analysis

02

Conditions studied

  • Cirrhosis

Keywords

  • Oncology
  • Hepatology
  • Public Health
  • Liver
03

In context

Fibrosis

3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.

This study's enrollment of 75,868 is above the median of 110 across 973 observational studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cirrhotic patients aged between 18 and 75 years

Inclusion criteria

- Cirrhotic patients aged between 18 and 75 years.

(A cirrhotic patient will be defined as a presenting a first occurrence of a codes used in hospitalisation for cirrhosis or as a motive for granting an ALD 6 (cirrhosis motivated) financial support )

Exclusion criteria

Exclusion Criteria:

- None

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
75,868 participants (actual)
Patient registry
No

Interventions

  • OtherDescription of the cirrhosis management
06

What researchers measure

Primary outcomes

  1. Rate of deviation from the guidelines

    Time frame: 01/01/2007 - 01/01/2018

Secondary outcomes

  1. Factors associated with deviation from the guidelines

    A multivariate regression analysis will be performed to objectivate factors associated with the deviation among sex, poor social status, Charlson index, age at inclusion and the alcoholic aetiology of the cirrhosis, type facility where hospitalisation occurred, number of hepatologist visits and living area

    Time frame: 01/01/2007 - 01/01/2018

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80084, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02983968
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Dec 6, 2016
Start date
Sep 7, 2016
Primary completion
Apr 9, 2019
Completion
Apr 9, 2019
Last update
Jun 12, 2026

Study contacts

Olivier GANRY, MD, PhD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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