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Identification of New Serum Diagnostic Markers of Hepatocellular Carcinoma

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. Identifier: NCT00373347
Recruitment Status : Recruiting
First Posted : September 8, 2006
Last Update Posted : February 8, 2019
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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 or disease
Liver Cancer

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of New Serum Diagnostic Markers of Hepatocellular Carcinoma
Study Start Date : November 2004
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00373347

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Contact: Mei-Sze Chua 650-724-3525

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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Mei-Sze Chua    650-724-3525   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Samuel So         
Sponsors and Collaborators
Stanford University
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Principal Investigator: Samuel So Stanford University

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Responsible Party: Stanford University Identifier: NCT00373347    
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 Posted: September 8, 2006    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases