Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

This study is currently recruiting participants.

Verified by Assistance Publique - Hôpitaux de Paris, March 2007

First Received: September 14, 2005 Last Updated: November 14, 2007 History of Changes

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

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: hemochromatosis

MedlinePlus related topics: Cancer Cirrhosis

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	AOM03009, CHC2000, CRC03042, AOM98038, P980902
Study First Received:	September 14, 2005
Last Updated:	November 14, 2007
ClinicalTrials.gov Identifier:	NCT00190385 History of Changes
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 Cirrhosis
Carcinoma
Liver Neoplasms
Digestive System Diseases

Hemochromatosis, Type 3
Hemochromatosis
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular Carcinoma
Ethanol
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Carcinoma, Hepatocellular
Fibrosis
Liver Cirrhosis
Carcinoma

Liver Neoplasms
Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009