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Trial record 3 of 6 for:    sylla

Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00190385
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 25, 2011
Sponsor:
Collaborators:
Ministry of Health, France
UNICANCER
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date February 25, 2011
Study Start Date  ICMJE July 2000
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2007)
Incidence of small hepatocellular carcinoma (HCC) [ Time Frame: 6 months versus 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Incidence of small HCC
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2007)
  • Survival [ Time Frame: during the study ]
  • Clinical value of serum alfa-fetoprotein assay [ Time Frame: during the study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
SurvivalClinical value of serum alfa-fetoprotein assay
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Condition  ICMJE Compensated Cirrhosis
Intervention  ICMJE Procedure: Ultrasonographic screening
Ultrasonographic screening
Study Arms  ICMJE Active Comparator: A
Intervention: Procedure: Ultrasonographic screening
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2005)
1200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00190385
Other Study ID Numbers  ICMJE AOM03009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sylla KHAOUSSOU, Department of Clinical Research of developpement
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE
  • Ministry of Health, France
  • UNICANCER
Investigators  ICMJE
Principal Investigator: Jean-Claude Trinchet, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP