Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-26 @ 5:46 PM
Study NCT ID:
NCT00902902
Status:
UNKNOWN
Last Update Posted:
2009-05-15
First Post:
2009-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of GP73 as a Hepatocellular Carcinoma (HCC) Tumor Mark
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
A Clinical Study of GP73 as a HCC Early Tumor Mark
Status:
UNKNOWN
Status Verified Date:
2009-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: