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Diagnosis of Hepatic Tumors in Cirrhosis: Prospective Validation of the Noninvasive Diagnostic Criteria for Hepatocellular Carcinoma (HCC)

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ClinicalTrials.gov Identifier: NCT00842647
Recruitment Status : Unknown
Verified April 2009 by Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : February 12, 2009
Last Update Posted : April 8, 2009
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by:
Sun Yat-sen University

Tracking Information
First Submitted Date February 11, 2009
First Posted Date February 12, 2009
Last Update Posted Date April 8, 2009
Study Start Date July 2006
Estimated Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnosis of Hepatic Tumors in Cirrhosis: Prospective Validation of the Noninvasive Diagnostic Criteria for Hepatocellular Carcinoma
Official Title Diagnosis of Hepatic Tumors in Cirrhosis: Prospective Validation of the Noninvasive Diagnostic Criteria for Hepatocellular Carcinoma
Brief Summary This study prospectively evaluates the accuracy of the noninvasive diagnostic criteria for hepatocellular carcinoma.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Between July 2006 and July 2009

  1. All the patients who receive hepatomy in our department
  2. Diagnose as HCC
  3. Diagnosis of HCC is confirmed by noninvasive criteria for HCC as used by the American Association for the Study of the Liver guidelines
  4. No history of previous treatments
  5. No pathological diagnosis before treatment
Condition Hepatocellular Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Bruix J, Sherman M. Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005;42:1208-1236 Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108. Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, et al. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol 2001;35:421-430. Fattovich G, Stroffolini T, Zagni I, Donato F. Hepatocellular carcinoma in cirrhosis: incidence and risk factors. Gastroenterology 2004;127:S35- S50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 7, 2009)
1200
Original Estimated Enrollment
 (submitted: February 11, 2009)
400
Estimated Study Completion Date August 2009
Estimated Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. All the patients who receive hepatomy in our department
  2. Diagnose as HCC
  3. Diagnosis of HCC is confirmed by noninvasive criteria for HCC as used by the American Association for the Study of the Liver guidelines
  4. No history of previous treatments
  5. No pathological diagnosis before treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00842647
Other Study ID Numbers HCC05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cancer Center, Sun Yat-sen University
Study Sponsor Sun Yat-sen University
Collaborators Ministry of Health, China
Investigators Not Provided
PRS Account Sun Yat-sen University
Verification Date April 2009