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
  Purpose

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.


Condition Intervention
Kidney Cancer
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: diagnostic laboratory biomarker analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Development of a Blood Test of Anti-IMP3 Autoantibody for the Detection of Renal Cell Carcinoma With Metastasis and Metastatic Potential

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Presence of metastatic renal cell carcinoma [ Time Frame: After blood draw prior to surgery or other treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: June 2008
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blood draw for diagnosis testing 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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806650

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: City of Hope Medical Center    800-826-4673      
Principal Investigator: Huiqing Wu, MD         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Huiqing Wu, MD City of Hope Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00806650     History of Changes
Other Study ID Numbers: 07241, P30CA033572, CHNMC-07241, CDR0000628796
Study First Received: December 10, 2008
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014