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Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

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ClinicalTrials.gov Identifier: NCT00190385
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 25, 2011
Sponsor:
Collaborators:
Ministry of Health, France
UNICANCER
Information provided by:
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Compensated Cirrhosis Procedure: Ultrasonographic screening Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : July 2000
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A Procedure: Ultrasonographic screening
Ultrasonographic screening


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of small hepatocellular carcinoma (HCC) [ Time Frame: 6 months versus 3 months ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: during the study ]
  2. Clinical value of serum alfa-fetoprotein assay [ Time Frame: during the study ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: March 2007

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

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