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Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

This study is currently recruiting participants.
Study NCT00190385.   Last updated on November 14, 2007.   Information provided by Assistance Publique - Hôpitaux de Paris

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Descriptive Information Fields
Brief Title  Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis
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
Brief Summary

Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors is currently recommended, but the best periodicity is unknown.This randomized trial is aimed to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.

Detailed Description

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 Phase Phase III
Study Type  Interventional
Study Design  Other, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary Outcome Measure  Incidence of small hepatocellular carcinoma (HCC) [ Time Frame: 6 months versus 3 months ]
Secondary Outcome Measure  Survival [ Time Frame: during the study ]
Clinical value of serum alfa-fetoprotein assay [ Time Frame: during the study ]
Condition  Compensated Cirrhosis
Intervention  Procedure: Ultrasonographic screening
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  1200
Start Date  July 2000
Completion Date July 2009
Eligibility Criteria 

Inclusion Criteria:

  • Compensated cirrhosis

Exclusion Criteria:

  • Antecedent of osmic acid synoviorthesis or of isotopic synoviorthesis of the studied knee
  • Intra-articular injection of triamcinolone hexacetonide in three months preceding the inclusion or by a different corticoid in the month preceding the inclusion
  • Evolutionary infectious or neoplastic pathology
Gender Both
Ages 30 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Jean-Claude Trinchet, Pr, MD, PhD     +33(0)-1 48 02 62 80     jean-claude.trinchet@jvr.aphp.fr    
Location Countries  France
Administrative Information Fields
NCT ID  NCT00190385
Organization ID AOM03009
Secondary IDs †† CHC2000, CRC03042, AOM98038, P980902
Study Sponsor  Assistance Publique - Hôpitaux de Paris
Collaborators †† Ministry of Health, France
Federation Nationale des Centres de Lutte Contre le Cancer
Investigators 
Principal Investigator:     Jean-Claude Trinchet, Pr, MD, PhD     Assistance Publique - Hôpitaux de Paris    
Information Provided By Assistance Publique - Hôpitaux de Paris
Verification Date March 2007
First Received Date  September 14, 2005
Last Updated Date November 14, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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