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

• ClinicalTrials.gov Identifier: NCT01798173
• Recruitment Status: Unknown
• First Posted: February 25, 2013
• Last Update Posted: July 29, 2016
• Sponsor: Centre Hospitalier Universitaire Dijon
• Information provided by (Responsible Party): Centre Hospitalier Universitaire Dijon

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Cirrhosis With Hepatocellular Carcinoma; Cirrhosis Without Hepatocellular Carcinoma	Biological: Serum, plasma and DNA samples; Procedure: Radiological exploration by CT scan or MRI	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: CIRCE: Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients
• Study Start Date: June 2008
• Estimated Primary Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Dosage of the vitamin B12 and the folates [ Time Frame: Baseline ]

Eligibility Criteria

• Ages Eligible for Study: 35 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT01798173
• Other Study ID Numbers: HILLON HORS AOI 2008
• First Posted: February 25, 2013
• Last Update Posted: July 29, 2016
• Last Verified: February 2013

Keywords provided by Centre Hospitalier Universitaire Dijon:

Hepatocellular carcinoma; Cirrhosis; Environmental risk factors; Nutrition; Metabolic syndrome

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis; Fibrosis; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes