Working… Menu
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. Identifier: NCT00190385
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 25, 2011
Ministry of Health, France
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Compensated Cirrhosis Procedure: Ultrasonographic screening Phase 3

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
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

Arm Intervention/treatment
Active Comparator: A Procedure: Ultrasonographic screening
Ultrasonographic screening

Primary Outcome Measures :
  1. Incidence of small hepatocellular carcinoma (HCC) [ Time Frame: 6 months versus 3 months ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: during the study ]
  2. Clinical value of serum alfa-fetoprotein assay [ Time Frame: during the study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00190385

Layout table for location information
Hopital Jean Verdier
Paris, Ile de France, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Layout table for investigator information
Principal Investigator: Jean-Claude Trinchet, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sylla KHAOUSSOU, Department of Clinical Research of developpement Identifier: NCT00190385    
Other Study ID Numbers: AOM03009
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: March 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hepatocellular carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Hepatocellular
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes