Status:
COMPLETED
Study of Hepatocellular Carcinoma in Cirrhotic Patients
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
35-70 years
Brief Summary
The project is based on a case-control study including cirrhotic patients with (200 cases) and without (400 controls) Hepatocellular carcinoma. The determination of sample sizes in proteomic or spectr...
Eligibility Criteria
Inclusion
- Cases and controls will be males aged 35 or older, and will give an informed consent to participate in the study. All HCC cases evolving in cirrhotic liver, whatever the etiology of cirrhosis, will be included. Criteria for the diagnosis of HCC will be those defined by the European Association for Study of the Liver (EASL) (Bruix J, J Hepatol 2001): All patients with cirrhosis, whatever its etiology, will be included. The diagnosis of cirrhosis will rely on histological confirmation by liver 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 nails, 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 \>18 mm Hg In the present state of knowledge, a fibrotest value at 4 or a fibroscan value \> 12,5 kPa Without any other clinical or biological signs will be considered as diagnosis criteria of cirrhosis only for chronic viral C hepatitis. The lack of HCC 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
- \- patients under 35years old or more than 75 years of age
- other cancer in evolution
- HIV infection
- major somatic or psychiatric illness not compatible with the inclusion in the study
- non HCC primary liver cancer.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01904942
Start Date
October 1 2008
Last Update
July 22 2013
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