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| Tracking Information | |||||
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| First Received Date ICMJE | September 14, 2005 | ||||
| Last Updated Date | November 14, 2007 | ||||
| Start Date ICMJE | July 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Incidence of small hepatocellular carcinoma (HCC) [ Time Frame: 6 months versus 3 months ] | ||||
| Original Primary Outcome Measures ICMJE |
Incidence of small HCC | ||||
| Change History | Complete list of historical versions of study NCT00190385 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
SurvivalClinical value of serum alfa-fetoprotein assay | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis | ||||
| Official Title ICMJE | 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. |
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| 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). |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Compensated Cirrhosis | ||||
| Intervention ICMJE | Procedure: Ultrasonographic screening | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1200 | ||||
| Estimated Completion Date | July 2009 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00190385 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | AOM03009, CHC2000, CRC03042, AOM98038, P980902 | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | March 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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