CIRCE - Case-Control Study on Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients

Head :
Hillon Patrick

Last update : 07/03/2015 | Version : 1 | ID : 9117

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Case-Control Study on Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients
Sign or acronym CIRCE
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL, CPP
General Aspects
Medical area Gastroenterology et hepatology
Health determinants Climate
Geography
Lifestyle and behavior
Nutrition
Occupation
Pollution
Keywords carcinogenesis, cirrhosis, HCC, nutrition, physical activity
Scientific investigator(s) (Contact)
Name of the director Hillon
Surname Patrick
Address Complexe du Bocage 14 rue Paul Gaffarel 21000 DIJON
Phone +33 (0)3 80 29 37 50
Email patrick.hillon@chu-dijon.fr
Organization CHU de
Collaborations
Participation in projects, networks and consortia Yes
Details ProSpec study (proteomics)
Funding
Funding status Public
Details Dijon UHC
Governance of the database
Sponsor(s) or organisation(s) responsible CHU de Dijon
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Case control study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Database objective
Main objective Little data are available on carcinogenesis mechanisms in cirrhotic patients and associated risk factors. This clinical, biochemical and molecular case-control study may be relevant to the understanding of nutrition, physical activity, metabolic syndrome and lipids (CiRCE Lip's study) in the development of hepatocellular carcinoma (HCC), regardless of the aetiology of the underlying cirrhosis.
It will open new perspectives in HCC prevention through dietary counselling and metabolic syndrome therapeutics and identify predictive HCC markers in cirrhotic patients (CiRCE ProSpec study), as well as new therapeutic targets for the treatment of cancer with challenging prognosis.
Inclusion criteria - Aged 35 or over;
- Informed consent.

Cirrhotic cases:
- Patients with hepatocellular carcinoma cases from liver cirrhosis, regardless of the cause of the cirrhosis.
- Criteria for hepatocellular carcinoma diagnosis: European Association for Study of the Liver (EASL);
Focal hepatic lesions greater or equal to 2 cm in diameter:
- Alpha-fetoprotein (AFP) below 400 ng/ml: nodules must be identified by at least two morphological examinations (abdominal ultrasound, angiography, CT or MRI);
- AFP over 400 ng/ml: lesion seen in a single imaging procedure;


Focal hepatic lesions less 2 cm in diameter:
- Lesions 1 to 2 cm in diameter: use of fine-needle aspiration with biopsy;
- Lesions less than 1 cm: serial abdominal ultrasound every 3 months until the lesion exceeds 1 cm in size so that biopsy becomes possible. These cases will be included at time of diagnosis.

Cirrhotic control patients:
- Histological confirmation by liver biopsy or in the absence of biopsy:
- In patients with no portal thrombosis at Doppler imaging, on the presence of portal hypertension confirmed by biological, morphological, hepatic venous pressure measurements or upper endoscopy.
- In patients with portal thrombosis, on the presence of portal hypertension associated with clinical or morphological signs of cirrhosis.
- Biological signs of hepatocellular failure.
- Lack of HCC at baseline through imaging examinations.



Exclusion criteria:
- Other cancer;
- HIV infection;
- Major somatic or psychiatric illness not compatible for inclusion in the study.

1,179 cirrhotic patients with (436 cases) or without (743 controls) HCC were enrolled in the CiRCE study.
Population type
Age Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area Besançon, Dijon, Metz, Reims, Strasbourg and Vandœuvre-lès-Nancy.
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 06/2008
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 1,179: - 436 cas/cases or without - 743 témoins/controls
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Paraclinical data
Biological data
Clinical data (detail) Medical registration
Details of collected clinical data --
Declarative data (detail) Face to face interview
Details of collected declarative data --
Paraclinical data (detail) Ultrasound, CT, MRI.
Biological data (detail) Dosage of vitamin B12 and folates.
Presence of a biobank Yes
Contents of biobank Serum
Plasma
DNA
Details of biobank content Serum, plasma, DNA.
Health parameters studied Health event/morbidity
Procedures
Participant monitoring No
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Through publications. Contact the scientist in charge for further information.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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