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

35 Years
Open (Enrolling)
Cirrhosis With Hepatocellular Carcinoma, Cirrhosis Without Hepatocellular Carcinoma

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Trial Information

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

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

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,

- 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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Dosage of the vitamin B12 and the folates

Outcome Time Frame:


Safety Issue:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

June 2008

Completion Date:

Related Keywords:

  • Cirrhosis With Hepatocellular Carcinoma
  • Cirrhosis Without Hepatocellular Carcinoma
  • Hepatocellular carcinoma
  • Cirrhosis
  • Environmental risk factors
  • Nutrition
  • Metabolic syndrome
  • Carcinoma
  • Liver Cirrhosis
  • Fibrosis
  • Carcinoma, Hepatocellular