Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients (CIRCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01798173
First received: January 4, 2013
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

Available data do not allow carcinogenesis mechanisms in cirrhotic patients to be well understood in absence of studies taking into account all recognised factors. A large scale clinical, biochemical and molecular studies is potentially relevant to the understanding of nutrition, physical activity, body weight metabolic syndrome whatever the etiology of underlying cirrhosis. It will open new perspectives :

  • in prevention of hepatocellular carcinoma development in cirrhotic patients through dietary counselling and therapeutics of metabolic syndrome,
  • in early screening of hepatocellular carcinoma in cirrhotic patients through spectroscopic technology and later proteomic study resulting in an improvement of hepatocellular carcinoma prognosis.

Condition Intervention
Cirrhosis With Hepatocellular Carcinoma
Cirrhosis Without Hepatocellular Carcinoma
Biological: Serum, plasma and DNA samples
Procedure: Radiological exploration by CT scan or MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CIRCE: Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Dosage of the vitamin B12 and the folates [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: June 2008
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cases: cirrhotic patients with hepatocellular carcinoma Biological: Serum, plasma and DNA samples Procedure: Radiological exploration by CT scan or MRI
Active Comparator: Controls: cirrhotic patients without hepatocellular carcinoma Biological: Serum, plasma and DNA samples Procedure: Radiological exploration by CT scan or MRI

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cases and controls will be males and females aged 35 or older, and will give an informed consent to participate in the study.

* Hepatocellular carcinoma case:

All hepatocellular carcinoma cases evolving in cirrhotic liver, whatever the etiology of cirrhosis, will be included. Criteria for the diagnosis of hepatocellular carcinoma will be those defined by the European Association for Study of the Liver (EASL) (Bruix J, J Hepatol 2001):

Focal hepatic lesions ≥ 2cm in diameter:

  • alpha-fetoprotein (AFP) < 400 ng/ml: nodules have to be identified by at least two coincident morphologic examinations (abdominal US, angiography, CT or MRI) with arterial hypervascularisation in at least one of the imaging modalities
  • AFP > 400 ng/ml: lesion seen in a single imaging modality

Focal hepatic lesions < 2 cm in diameter:

  • lesions 1 to 2 cm in diameter:use of fine-needle aspiration with biopsy
  • lesions < 1 cm: serial abdominal US every 3 months until the lesion exceeds 1 cm in size so that biopsy becomes possible. Such cases will be included after diagnosis confirmation.

Whatever the size of focal lesions, the diagnosis of cirrhosis will be made according to the same criteria as in the cirrhotic group control.

* Cirrhotic control patients:

All patients with cirrhosis, whatever its etiology, will be included. The diagnosis of cirrhosis will rely on:

Histological confirmation by liver biopsy or in the absence of biopsy:

  • in patients free of portal thrombosis at Doppler imaging, on the presence of portal hypertension ascertained by biological (tricytopenia), morphologic (abdominal US, CT or MRI), hepatic venous pressure measurement or upper endoscopy (mosaic gastropathy, varices).
  • in patients with portal thrombosis, on the presence of portal hypertension associated with: Clinical (hepatomegaly with clinical evidence of hepatocellular failure: spider naevi, palmar erythema, white mails, gynecomastia) or morphological signs of cirrhosis (enlarged liver, nodular surface, sharp lower edge).

And/or biological signs of hepatocellular failure (TP<70%, low albuminemia) And/or sinusoidal block assessed by liver venous gradient > 18mmHG In the present state of knowledge, a fibrotest value at 4 or a fibroscan value > 12.5 kilopascal.

Without any other clinical or biological signs will be considered as diagnosis criteria of cirrhosis only for chronic viral C hepatitis.

The lack of hepatocellular carcinoma in cirrhotic patients at inclusion will be assessed through good quality imaging examinations (abdominal US, CT scan or MRI) and AFP below 100 ng/ml.

Exclusion Criteria:

  • age under 35 of year
  • other cancer in evolution
  • HIV infection
  • Major somatic pr psychiatric illness not compatible with the inclusion in the study
  • No hepatocellular carcinoma primary liver cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798173

Contacts
Contact: Patrick HILLON 3 80 29 37 50 ext +33 patrick.hillon@chu-dijon.fr

Locations
France
Hôpital Jean Minjoz Recruiting
Besancon, France, 25000
Contact: Carine RICHOU    3 81 66 84 21 ext +33      
Principal Investigator: Carine RICHOU         
Sub-Investigator: Jean-Paul CERVONI         
Sub-Investigator: Vincent DI MARTINO         
Sub-Investigator: Thierry THEVENOT         
Hôpital du Bocage Recruiting
Dijon, France, 21079
Contact: Jean-Louis JOUVE    3 80 29 37 50 ext +33      
Principal Investigator: Jean-Louis JOUVE         
Sub-Investigator: Laurent BEDENNE         
Sub-Investigator: Jean FAIVRE         
Sub-Investigator: Patrick HILLON         
Sub-Investigator: Come LEPAGE         
Sub-Investigator: Anne MINELLO         
Sub-Investigator: Alice GAGNAIRE         
Sub-Investigator: Boris GUIU         
Centre Hospitalier de METZ Recruiting
Metz, France, 57038
Contact: Jean-Jacques RAABE    3 87 55 33 50 ext +33      
Principal Investigator: Jean-Jacques RAABE         
Sub-Investigator: Brigitte LE GUILLOU         
CHU Robert DEBRE Recruiting
Reims, France, 51092
Contact: Gérard THIEFFIN    3 26 78 37 65 ext +33      
Principal Investigator: Gérard THIEFFIN         
Sub-Investigator: Olivier BOUCHE         
Sub-Investigator: Alexandra HEURGUE         
Sub-Investigator: Brigitte BERNARD CHABERT         
Sub-Investigator: Stéphanie LAGARDE         
Sub-Investigator: Aude BERTIN         
Sub-Investigator: Elodie SCAGLIA         
Sub-Investigator: Florent EHRHARD         
Clinique médicale B. Hôpital Civil-Hôpitaux Universitaires Completed
Strasbourg, France, 67091
Hôpital de BRABOIS Completed
Vandoeuvre-les-nancy, France, 54511
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01798173     History of Changes
Other Study ID Numbers: HILLON HORS AOI 2008
Study First Received: January 4, 2013
Last Updated: February 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire Dijon:
Hepatocellular carcinoma
Cirrhosis
Environmental risk factors
Nutrition
Metabolic syndrome

Additional relevant MeSH terms:
Carcinoma
Liver Cirrhosis
Fibrosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on July 20, 2014