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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Clinical Study of GP73 as a HCC Early Tumor Mark

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00902902
• Other study ID #: PUMCH-Liver surgery -GP73
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2009
• Last updated: May 14, 2009
• Start date: January 2008
• Est. completion date: July 2009

Study information

• Verified date: May 2009
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The aims of this study were divided into three parts:

1. To evaluate the sensitivity and specificity of GP73 for the diagnosis of hepatitis B related HCC. Established the standard of GP73 in normal people.

2. To definitude the connections between the GP73 level and various diseases.

3. To find the relations of HCC metastasis and recurrence.

Study design:

1. Collectivity type: Prospective，randomized, controlled, multi-central clinical study.

2. 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:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: July 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

United States,