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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Peking Union Medical College Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT00902902
First received: May 13, 2009
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

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.

Condition
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Clinical Study of GP73 as a HCC Early Tumor Mark

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Biospecimen Retention:   Samples With DNA

Human serum


Estimated Enrollment: 0
Study Start Date: January 2008
Estimated Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00902902

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: M. Millis, Dr.       mmillis@surgery.bsd.uchicago.edu   
Principal Investigator: M Millis, M.D.         
Sponsors and Collaborators
Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Dr. Yilei Mao, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT00902902     History of Changes
Other Study ID Numbers: PUMCH-Liver surgery -GP73
Study First Received: May 13, 2009
Last Updated: May 14, 2009
Health Authority: China: Ethics Committee

Keywords provided by Peking Union Medical College Hospital:
Hepatocellular carcinoma

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

ClinicalTrials.gov processed this record on August 27, 2014