Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

November 14, 2007

Start Date ^ICMJE

July 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of small hepatocellular carcinoma (HCC) [ Time Frame: 6 months versus 3 months ]

Original Primary Outcome Measures ^ICMJE

Incidence of small HCC

Change History

Complete list of historical versions of study NCT00190385 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Survival [ Time Frame: during the study ]
Clinical value of serum alfa-fetoprotein assay [ Time Frame: during the study ]

Original Secondary Outcome Measures ^ICMJE

SurvivalClinical value of serum alfa-fetoprotein assay

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Compensated Cirrhosis

Intervention ^ICMJE

Procedure: Ultrasonographic screening

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1200

Estimated Completion Date

July 2009

Primary Completion Date

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

Gender

Both

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jean-Claude Trinchet, Pr, MD, PhD

+33(0)-1 48 02 62 80

jean-claude.trinchet@jvr.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00190385

Responsible Party

Study ID Numbers ^ICMJE

AOM03009, CHC2000, CRC03042, AOM98038, P980902

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Ministry of Health, France
Federation Nationale des Centres de Lutte Contre le Cancer

Investigators ^ICMJE

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

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