Autoantibody Blood Test in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer
This study is currently recruiting participants.
Verified January 2013 by City of Hope Medical Center
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00806650
First received: December 10, 2008
Last updated: January 7, 2013
Last verified: January 2013
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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 2013 (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
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: | January 7, 2013 |
| 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, 2013