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Identification of New Serum Diagnostic Markers of Hepatocellular Carcinoma

This study is currently recruiting participants.
Verified November 2016 by Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373347
First Posted: September 8, 2006
Last Update Posted: November 9, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
  Purpose
The aim of the study is to see if there any changes in the quality of life for patients that are undergoing radical prostatectomy.

Condition
Liver Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of New Serum Diagnostic Markers of Hepatocellular Carcinoma

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • measure quality of life changes for patients that are undergoing radical prostatectomy [ Time Frame: complete questionnaires prior to surgery, 3, 6, 12 and 24 months after surgery ]

Biospecimen Retention:   Samples With DNA
blood

Estimated Enrollment: 300
Study Start Date: November 2004
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Detailed Description:
Liver cancer is a deadly cancer that is typically hard to diagnose and treat. The currently used blood marker for the clinical diagnosis of liver cancer is alpha-feto protein (AFP), which misses 40-60% of patients with liver cancer because it lacks sufficient specificity and sensitivity. The purpose of this study is to identify blood markers that have the ability to diagnose liver cancer with improved accuracy, so that it can be used alone or in conjunction with AFP. The aim of this study is to identify new blood markers of liver cancer that can be used to increase the rate of accurate diagnosis of this malignancy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with liver cancer
Criteria

Inclusion Criteria:Patients diagnosed with liver cancer based on biopsy or serum AFP level, associated with characteristic hypervascular liver tumors on triphasic spiral CT scan or MRI.

  • Patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia.
  • Patients with hepatitis B or hepatitis C viral infections not associated with liver cancer.

Exclusion Criteria:Patients will be excluded if, upon looking through their medical records, information required for data analysis are missing.

  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): NCT00373347


Contacts
Contact: Mei-Sze Chua 650-724-3525 mchua@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Mei-Sze Chua    650-724-3525    mchua@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Samuel So         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Samuel So Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00373347     History of Changes
Other Study ID Numbers: HEP0006
95521 ( Other Identifier: Stanford University Alternate IRB Approval Number )
HEP0006 ( Other Identifier: Stanford University )
10767 ( Other Identifier: Stanford IRB )
First Submitted: September 6, 2006
First Posted: September 8, 2006
Last Update Posted: November 9, 2016
Last Verified: November 2016

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