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

Tracking Information

First Received Date ^ICMJE

December 10, 2008

Last Updated Date

June 23, 2009

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00806650 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Kidney Cancer

Intervention ^ICMJE

Genetic: gene expression analysis
Genetic: protein expression analysis
Other: diagnostic laboratory biomarker analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

230

Completion Date

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00806650

Responsible Party

Huiqing Wu, City of Hope Comprehensive Cancer Center

Study ID Numbers ^ICMJE

CDR0000628796, CHNMC-07241

Study Sponsor ^ICMJE

Beckman Research Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Huiqing Wu, MD

Beckman Research Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2009

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