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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), June 2009

First Received: December 10, 2008 Last Updated: June 23, 2009 History of Changes

Sponsor:	Beckman Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00806650

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:	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:

MedlinePlus related topics: Cancer Kidney Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Presence of metastatic renal cell carcinoma [ Designated as safety issue: No ]

Estimated Enrollment:	230
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

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

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

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Huiqing Wu, MD

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	City of Hope Comprehensive Cancer Center ( Huiqing Wu )
Study ID Numbers:	CDR0000628796, CHNMC-07241
Study First Received:	December 10, 2008
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00806650 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Pharmacologic Actions
Carcinoma
Neoplastic Processes
Neoplasms
Pathologic Processes

Neoplasms by Site
Autoantibodies
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasm Metastasis
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010