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Development of a Blood Test of Anti-IMP3 Autoantibody for the Detection of Renal Cell Carcinoma With Metastasis and Metastatic Potential


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N/A
N/A
Open (Enrolling)
Both
Kidney Cancer

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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 CenterDuarte, California  91010