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

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Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

This study is currently recruiting participants.

Study NCT00190385. Last updated on November 14, 2007. Information provided by Assistance Publique - Hôpitaux de Paris

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

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

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Compensated Cirrhosis

Intervention ^†

Procedure: Ultrasonographic screening

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

1200

Start Date ^†

July 2000

Completion Date

July 2009

Eligibility 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

Gender

Both

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

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

+33(0)-1 48 02 62 80

jean-claude.trinchet@jvr.aphp.fr

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00190385

Organization ID

AOM03009

Secondary IDs ^††

CHC2000, CRC03042, AOM98038, P980902

Study Sponsor ^†

Assistance Publique - Hôpitaux de Paris

Collaborators ^††

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

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

March 2007

First Received Date ^†

September 14, 2005

Last Updated Date

November 14, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.