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Identification of New Serum Diagnostic Markers of Hepatocellular Carcinoma

This study is currently recruiting participants.
Verified January 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00373347
First received: September 6, 2006
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

The objective of the study is to identify novel blood markers for the diagnosis of liver cancer. We will collect serum samples from consented patients and measure the levels of potential protein markers in their serum.


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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by Stanford University:

Biospecimen Retention:   Samples With DNA

blood


Estimated Enrollment: 300
Study Start Date: November 2004
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00373347     History of Changes
Other Study ID Numbers: HEP0006, 95521, HEP0006, 10767
Study First Received: September 6, 2006
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013