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

January 4, 2013
February 22, 2013
June 2008
December 2013   (final data collection date for primary outcome measure)
Dosage of the vitamin B12 and the folates [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01798173 on ClinicalTrials.gov Archive Site
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Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients
CIRCE: Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients

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.
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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cirrhosis With Hepatocellular Carcinoma
  • Cirrhosis Without Hepatocellular Carcinoma
  • Biological: Serum, plasma and DNA samples
  • Procedure: Radiological exploration by CT scan or MRI
  • Experimental: Cases: cirrhotic patients with hepatocellular carcinoma
    Interventions:
    • Biological: Serum, plasma and DNA samples
    • Procedure: Radiological exploration by CT scan or MRI
  • Active Comparator: Controls: cirrhotic patients without hepatocellular carcinoma
    Interventions:
    • Biological: Serum, plasma and DNA samples
    • Procedure: Radiological exploration by CT scan or MRI
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
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December 2013   (final data collection date for primary outcome measure)

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.
Both
35 Years and older
No
Contact: Patrick HILLON 3 80 29 37 50 ext +33 patrick.hillon@chu-dijon.fr
France
 
NCT01798173
HILLON HORS AOI 2008
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Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire Dijon
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Centre Hospitalier Universitaire Dijon
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP