Identification of New Serum Diagnostic Markers of Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00373347
First received: September 6, 2006
Last updated: June 18, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373347

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: June 18, 2014
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 July 24, 2014