Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190385
Status:
COMPLETED
Last Update Posted:
2011-02-25
First Post:
2005-09-14
Brief Title:
Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 unknownThis randomized trial is aimed to compare 6-month current recommendation and 3-month ultrasonographic screenings
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None