Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis - Full Text View

Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, March 2007

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Ministry of Health, France Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00190385

Purpose

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	Intervention	Phase
Compensated Cirrhosis	Procedure: Ultrasonographic screening	Phase III

Genetics Home Reference related topics:

hemochromatosis

MedlinePlus related topics:

Cancer Cirrhosis Liver Cancer

ChemIDplus related topics:

Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	1200
Study Start Date:	July 2000
Estimated Study Completion Date:	July 2009

Arms	Assigned Interventions
A: Active Comparator	Procedure: Ultrasonographic screening Ultrasonographic screening

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).

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190385

Contacts


Contact: Jean-Claude Trinchet, Pr, MD, PhD	+33(0)-1 48 02 62 80	jean-claude.trinchet@jvr.aphp.fr

Locations


France, Ile de France
	Assistance Publique-Hôpitaux de Paris	Recruiting
	Paris, Ile de France, France, 75010
	Contact: Jean-Claude Trinchet, Pr, MD, PhD +33(0)-1 48 02 62 80 jean-claude.trinchet@jvr.aphp.fr
	Hopital Jean Verdier	Recruiting
	Paris, Ile de France, France, 75010
	Contact: Jean-Claude Trinchet, Pr, MD, PhD +33(0)-1 48 02 62 80 jean-claude.trinchet@jvr.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

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

More Information

Study ID Numbers:	AOM03009, CHC2000, CRC03042, AOM98038, P980902
First Received:	September 14, 2005
Last Updated:	November 14, 2007
ClinicalTrials.gov Identifier:	NCT00190385
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Cirrhosis

Hepatocellular carcinoma

Screening

Randomized

HBV

HCV

alcohol

hemochromatosis

Study placed in the following topic categories:

Liver Diseases

Digestive System Neoplasms

Carcinoma, Hepatocellular

Fibrosis

Liver neoplasms

Hemochromatosis, type 3

Liver Cirrhosis

Carcinoma

Liver Neoplasms

Digestive System Diseases

Hemochromatosis

Gastrointestinal Neoplasms

Adenocarcinoma

Ethanol

Neoplasms, Glandular and Epithelial

Hepatocellular carcinoma

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 05, 2008