Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

This study is currently recruiting patients. Verified by Assistance Publique - Hôpitaux de Paris March 2005

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 screening.

Condition	Intervention	Phase
Compensated Cirrhosis (HBV, HCV, Alcohol, Hemochromatosis)	Procedure: Ultrasonographic screening	Phase III

MedlinePlus consumer health information

Study Type: Interventional
Study Design: Prevention, 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 Outcomes: Incidence of small HCC
Secondary Outcomes: SurvivalClinical value of serum alfa-fetoprotein assay
Expected Total Enrollment: 1200

Study start: July 2000; Expected completion: August 2009
Last follow-up: July 2009; Data entry closure: July 2009

- 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 vs 6-month); serum alfa-fetoprotein assay (none vs 6-month).- End points: rate of small tumors (first main criteria); survival (second main criteria).

Eligibility

Ages Eligible for Study: 30 Years - 75 Years, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Compensated cirrhosis

Exclusion Criteria:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00190385

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

France, Ile De France
Assistance Publique-Hopitaux De Paris, PARIS, Ile De France, 75010, France; Recruiting

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

Hopital Jean Verdier, PARIS, Ile De France, 75010, France; Recruiting

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

Study chairs or principal investigators

Jean-Claude TRINCHET, Pr, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris

More Information

Study ID Numbers: AOM03009; CHC2000; CRC03042; AOM98038; P980902
Last Updated: April 7, 2006
Record first received: September 14, 2005
ClinicalTrials.gov Identifier: NCT00190385
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2006-10-10

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris PHRC (1998 and 2003 grants) Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00190385

Resources

Dr Whittingtons Book

Free Articles on Hemochromatosis

CDC Hemochromatosis Brochure

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