Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis
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|ClinicalTrials.gov Identifier: NCT00190385|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Compensated Cirrhosis||Procedure: Ultrasonographic screening||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (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|
|Study Start Date :||July 2000|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
|Active Comparator: A||
Procedure: Ultrasonographic screening
- Incidence of small hepatocellular carcinoma (HCC) [ Time Frame: 6 months versus 3 months ]
- Survival [ Time Frame: during the study ]
- Clinical value of serum alfa-fetoprotein assay [ Time Frame: during the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190385
|Hopital Jean Verdier|
|Paris, Ile de France, France, 75010|
|Principal Investigator:||Jean-Claude Trinchet, Pr, MD, PhD||Assistance Publique - Hôpitaux de Paris|