Autoantibody Blood Test in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00806650
First received: December 10, 2008
Last updated: July 31, 2014
Last verified: July 2014

December 10, 2008
July 31, 2014
June 2008
November 2015   (final data collection date for primary outcome measure)
Presence of metastatic renal cell carcinoma [ Time Frame: After blood draw prior to surgery or other treatment ] [ Designated as safety issue: No ]
Presence of metastatic renal cell carcinoma [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00806650 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Autoantibody Blood Test in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer
Development of a Blood Test of Anti-IMP3 Autoantibody for the Detection of Renal Cell Carcinoma With Metastasis and Metastatic Potential

RATIONALE: Studying specific autoantibodies in blood samples from patients with cancer may help doctors find metastasis and help plan cancer treatment.

PURPOSE: This clinical trial is studying an autoantibody blood test in finding metastasis in patients with localized or metastatic kidney cancer.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Kidney Cancer
  • Genetic: gene expression analysis
    Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
  • Genetic: protein expression analysis
    Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
  • Other: diagnostic laboratory biomarker analysis
    Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
  • Other: immunoenzyme technique
    Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
  • Other: immunohistochemistry staining method
    Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples
Experimental: Blood draw for diagnosis testing
Interventions:
  • Genetic: gene expression analysis
  • Genetic: protein expression analysis
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunoenzyme technique
  • Other: immunohistochemistry staining method
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
Not Provided
November 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
United States
 
NCT00806650
07241, P30CA033572, CHNMC-07241, CDR0000628796
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Huiqing Wu, MD City of Hope Medical Center
City of Hope Medical Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP