Autoantibody Blood Test in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer - Full Text View

Sponsor:	City of Hope Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	City of Hope Medical Center
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:	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:

MedlinePlus related topics: Cancer Kidney Cancer

U.S. FDA Resources

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:	June 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

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: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org
Principal Investigator: Huiqing Wu, MD

Sponsors and Collaborators

City of Hope Medical Center

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 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:	November 7, 2011
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
Neoplasm Metastasis
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms

Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012