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Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
UNICANCER
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190385
First received: September 14, 2005
Last updated: February 24, 2011
Last verified: March 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
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:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Clinical value of serum alfa-fetoprotein assay [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Enrollment: 1200
Study Start Date: July 2000
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Procedure: Ultrasonographic screening
Ultrasonographic screening
Other Name: 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

Locations
France
Hopital Jean Verdier
Paris, Ile de France, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
UNICANCER
Investigators
Principal Investigator: Jean-Claude Trinchet, Pr, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sylla KHAOUSSOU, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00190385     History of Changes
Other Study ID Numbers: AOM03009
Study First Received: September 14, 2005
Last Updated: February 24, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cirrhosis
Hepatocellular carcinoma
Screening
Randomized
 HBV
HCV
alcohol
hemochromatosis

Additional relevant MeSH terms:
Carcinoma
Liver Cirrhosis
Fibrosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Liver Diseases
Digestive System Diseases
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 21, 2013