A Clinical Study of GP73 as a Hepatocellular Carcinoma (HCC) Tumor Mark

May 14, 2009 updated by: Peking Union Medical College Hospital

A Clinical Study of GP73 as a HCC Early Tumor Mark

The aims of this study were divided into three parts:

To evaluate the sensitivity and specificity of GP73 for the diagnosis of hepatitis B related HCC. Established the standard of GP73 in normal people.
To definitude the connections between the GP73 level and various diseases.
To find the relations of HCC metastasis and recurrence.

Study design:

Collectivity type: Prospective，randomized, controlled, multi-central clinical study.
Patients: The subjects were from different hospitals including: Peking Union Medical College Hospital (PUMCH), The Cancer Hospital of Peking Union Medical College (PUMC), QiDong Cancer Institute, and Department of Surgery University of Chicago from November of 2007 till the end of this study.

Study arrangement:

This study was consisted of three parts:

Established the standard of normal people and test the sensitivity and specificity of HCC patients. The samples were acquired from Health Screen Center and Department of liver surgery of PUMCH, The Cancer Hospital of PUMC and QiDong Cancer Institute.
Extend the study bound, including the hepatitis B virus (HBV) and hepatitis C virus (HCV) carriers. The HBV (+) samples were come from Chinese hospitals and institutions. The HCV (+) samples were provide by the Department of Surgery University of Chicago.
Research the relations of serum GP73 level and the other diseases, such as other malignant liver tumors, liver metastatic tumors, liver benign tumor, HCC recurrence following surgery etc.

Study Overview

Status

Unknown

Conditions

Hepatocellular Carcinoma

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - The University of Chicago
    - Contact:
      
      M. Millis, Dr.
      
      Email: mmillis@surgery.bsd.uchicago.edu
    - Principal Investigator:
      
      M Millis, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The subjects were from different hospitals including: Peking Union Medical College Hospital, The Cancer Hospital of PUMC, QiDong Cancer Institute, and Department of Surgery University of Chicago from November of 2007 till the end of this study.

Description

Inclusion Criteria:

A group of patients with no history of liver disease, alcohol consumption less than 40g a week, and no risk factors for viral hepatitis were enrolled from the General Internal Medicine clinics. All subjects in this control group were documented to have normal liver biochemistry.
Consecutive patients with HCC and patients with HBV & HCV that were age, gender, and race/ethnicity matched to the HCC patients were enrolled from the Liver Clinic during this period. The diagnosis of HCC was made by histopathology, and if histopathology was not available by two imaging modalities (ultrasound [US], magnetic resonance imaging [MRI], or computed tomography) showing a vascular enhancing mass >2cm. HBV infection status was based on hepatitis B surface antigen (HBsAg). HCV infection status was based on serum HCV antibody and HCV-RNA positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1
2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (Estimate)

May 15, 2009

Study Record Updates

Last Update Posted (Estimate)