Development of a Blood Test of Anti-IMP3 Autoantibody for the Detection of Renal Cell Carcinoma With Metastasis and Metastatic Potential
N/A
N/A
Both
Kidney Cancer
Trial Information
Development of a Blood Test of Anti-IMP3 Autoantibody for the Detection of Renal Cell Carcinoma With Metastasis and Metastatic Potential
OBJECTIVES:
- To develop an anti-IMP3 autoantibody blood test to identify the status of current and
potential metastasis in patients with localized or metastatic renal cell carcinoma.
OUTLINE: Serum samples obtained prior to surgery are analyzed for anti-IMP3 autoantibody by
ELISA. Tissue samples obtained at the time of surgery are examined for IMP3 gene
overexpression by IHC. The results of the ELISA serum assay are then compared with the
results of the IHC tissue analysis to evaluate the sensitivity and specificity of the assay.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of renal cell carcinoma (RCC)
- Localized or metastatic disease
- Undergoing surgery at the City of Hope National Medical Center to remove primary
and/or metastatic lesions
- Serum and tissue samples available, including any of the following:
- Discarded or left-over plasma/serum samples from the Blood Bank of the
Department of Transfusional Medicine
- Formalin-fixed paraffin-embedded (FFPE) and/or frozen primary and/or metastatic
RCC tissue samples
- FFPE and/or frozen benign renal tissue samples that are near the tumor and
removed during surgery
- Discarded or leftover FFPE and/or frozen renal tissue samples from the
Department of Anatomic Pathology and its Tumor Bank
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Presence of metastatic renal cell carcinoma
Outcome Time Frame:
After blood draw prior to surgery or other treatment
Safety Issue:
No
Principal Investigator
Huiqing Wu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Institutional Review Board
Study ID:
07241
NCT ID:
NCT00806650
Start Date:
June 2008
Completion Date:
Related Keywords:
- Kidney Cancer
- stage I renal cell cancer
- stage II renal cell cancer
- stage III renal cell cancer
- stage IV renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| City of Hope Medical Center | Duarte, California 91010 |
