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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Ministry of Health, France Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00190385 |
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 |
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Compensated Cirrhosis |
Procedure: Ultrasonographic screening |
Phase III |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 1200 |
Study Start Date: | July 2000 |
Estimated Study Completion Date: | July 2009 |
Arms | Assigned Interventions |
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A: Active Comparator |
Procedure: Ultrasonographic screening
Ultrasonographic screening
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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).
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: 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-Hôpitaux de Paris | Recruiting |
Paris, Ile de France, France, 75010 | |
Contact: Jean-Claude Trinchet, Pr, MD, PhD +33(0)-1 48 02 62 80 jean-claude.trinchet@jvr.aphp.fr | |
Hopital Jean Verdier | Recruiting |
Paris, Ile de France, France, 75010 | |
Contact: Jean-Claude Trinchet, Pr, MD, PhD +33(0)-1 48 02 62 80 jean-claude.trinchet@jvr.aphp.fr |
Principal Investigator: | Jean-Claude Trinchet, Pr, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | AOM03009, CHC2000, CRC03042, AOM98038, P980902 |
Study First Received: | September 14, 2005 |
Last Updated: | November 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00190385 |
Health Authority: | France: Ministry of Health |
Cirrhosis Hepatocellular carcinoma Screening Randomized |
HBV HCV alcohol hemochromatosis |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Fibrosis Liver neoplasms Hemochromatosis, type 3 Liver Cirrhosis Carcinoma |
Liver Neoplasms Digestive System Diseases Hemochromatosis Gastrointestinal Neoplasms Adenocarcinoma Ethanol Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Pathologic Processes Neoplasms by Site Neoplasms by Histologic Type |