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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Sun Yat-sen University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842647
First Posted: February 12, 2009
Last Update Posted: April 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, China
Information provided by:
Sun Yat-sen University
  Purpose
This study prospectively evaluates the accuracy of the noninvasive diagnostic criteria for hepatocellular carcinoma.

Condition
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnosis of Hepatic Tumors in Cirrhosis: Prospective Validation of the Noninvasive Diagnostic Criteria for Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Estimated Enrollment: 1200
Study Start Date: July 2006
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
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): NCT00842647


Contacts
Contact: Min-Shan Chen, MD 86-2087343117 ext 86-2087343117 Chminsh@mail.sysu.edu.cn

Locations
China, Guangdong
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Min-Shan Chen, MD    86-2087343117    Chminsh@mail.sysu.edu.cn   
Principal Investigator: Min-Shan Chen, MD         
Sponsors and Collaborators
Sun Yat-sen University
Ministry of Health, China
  More Information

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.

Responsible Party: Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00842647     History of Changes
Other Study ID Numbers: HCC05
First Submitted: February 11, 2009
First Posted: February 12, 2009
Last Update Posted: April 8, 2009
Last Verified: April 2009

Keywords provided by Sun Yat-sen University:
Sensitivity
specificity
positive rate
negative rate

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