Skip to main content
OpenTrials
Completed

NCT Number: NCT00190385

Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Compensated Cirrhosis Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Fibrosis Genetic Diseases, Inborn Hemochromatosis Iron Metabolism Disorders Iron Overload Liver Diseases Liver Neoplasms Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital Jean Verdier

Paris, Île-de-France Region, 75010, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonographic screening

Procedure

Ultrasonographic screening

Primary outcomes

  1. Incidence of small hepatocellular carcinoma (HCC)

    Time frame: 6 months versus 3 months

Secondary outcomes

  1. Survival

    Time frame: during the study

  2. Clinical value of serum alfa-fetoprotein assay

    Time frame: during the study

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France
  • UNICANCER

Registry information

Official study title

Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis. A Randomized Trial Comparing Two Periodicities of Ultrasonographic Surveillance: 3-month vs 6-month

Important dates

Study start
2000
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Feb 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.