Anti-IMP3 Autoantibody and MicroRNA Signature Blood Tests in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer
This research trial studies the development of a blood test for detecting anti-insulin-like growth factor II mRNA binding protein 3 (anti-IMP3) antibody and micro ribonucleic acid (microRNA) in patients with renal cell carcinoma (RCC) that has spread to other parts of the body (metastatic) or is limited to the tissue or organ where it began (localized). Anti-IMP3 is a tumor marker that can be detected in many human cancers, including RCC and is likely to be present in the serum (blood) of patients with metastatic or localized RCC. Alterations in microRNA expression has also shown to play a critical role in cancer progression and may be a promising biomarker for patients with RCC. Developing a blood test for anti-IMP3 antibody and microRNA in serum and tissue samples of patients in the laboratory may help doctors find and diagnose RCC earlier, find out how far the disease has spread, and plan effective treatment for RCC.
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: diagnostic laboratory biomarker analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Development of a Blood Test of Anti-IMP3 Autoantibody and Serum MicroRNA Signature for the Detection of Renal Cell Carcinoma With Metastasis and Metastatic Potential|
- Presence of primary and/or metastatic renal cell carcinoma [ Time Frame: Baseline ] [ Designated as safety issue: No ]For the IMP3 autoantibody study, the results of IHC studies of IMP3 on the tissue sections will be used as golden standard to evaluate the sensitivity and specificity of the assay. For the IMP3 autoantibody study, the results of IHC studies of IMP3 on the tissue sections will be used as golden standard to evaluate the sensitivity and specificity of the assay. Statistical significance will be set at P < 0.05 (confidence level of 95%).
|Study Start Date:||June 2008|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
|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 samplesGenetic: protein expression analysis
Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samplesOther: 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 samplesOther: immunoenzyme technique
I. To develop a blood test by monitoring the titer of IMP3 autoantibody and/or microRNA (miRNA)/small non-coding RNA (snRNA) expression in patients' serum for the early detection of RCC and its recurrence/metastasis.
OUTLINE: Serum samples are collected prior to treatment and analyzed for anti-IMP3 autoantibody titer via via enzyme-linked immunosorbent assay (ELISA) and total RNA via sequencing, microarray, and/or quantitative polymerase chain reaction (q-PCR). Previously collected tissue samples are analyzed for IMP3 via immunohistochemistry (IHC).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806650
|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|
|Principal Investigator:||Huiqing Wu, MD||City of Hope Medical Center|