Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
|Official Title:||Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis. A Randomized Trial Comparing Two Periodicities of Ultrasonographic Surveillance: 3-month vs 6-month|
- Incidence of small hepatocellular carcinoma (HCC) [ Time Frame: 6 months versus 3 months ] [ Designated as safety issue: Yes ]
- Survival [ Time Frame: during the study ] [ Designated as safety issue: No ]
- Clinical value of serum alfa-fetoprotein assay [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2000|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
Procedure: Ultrasonographic screening
Patients: All consecutive patients with compensated HBV, HCV, alcohol or hemochromatosis-related cirrhosis (without any previous clinical complication including liver cancer).
Randomization: factorial: ultrasonography (3-month versus 6-month); serum alfa-fetoprotein assay (none versus 6-month).
End points: rate of small tumors (first main criteria); survival (second main criteria).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190385
|Hopital Jean Verdier|
|Paris, Ile de France, France, 75010|
|Principal Investigator:||Jean-Claude Trinchet, Pr, MD, PhD||Assistance Publique - Hôpitaux de Paris|