Use of the French Healthcare Insurance Database

NCT ID: NCT02983968

Last Updated: 2018-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

890 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-10-31

Brief Summary

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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).

Detailed Description

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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

Conditions

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Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Description of the cirrhosis management

Intervention Type OTHER

Eligibility Criteria

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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

\- None
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier GANRY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier GANRY, MD, PhD

Role: CONTACT

+33 3 66 81 93

Facility Contacts

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Olivier GANRY, MD, PhD

Role: primary

+33 3 66 81 93

Other Identifiers

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RNI2015-43 Pr Ganry

Identifier Type: -

Identifier Source: org_study_id

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NASH and Coronary Disease
NCT03819283 UNKNOWN NA