Anti-IMP3 Autoantibody and MicroRNA Signature Blood Tests in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00806650|
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment|
|Kidney Cancer||Genetic: gene expression analysis Genetic: protein expression analysis Diagnostic Test: diagnostic laboratory biomarker analysis Other: immunoenzyme technique Other: immunohistochemistry staining method|
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 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).
|Study Type :||Observational|
|Actual Enrollment :||155 participants|
|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|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||November 15, 2017|
|Actual Study Completion Date :||November 15, 2017|
|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 samplesDiagnostic Test: 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
- Presence of primary and/or metastatic renal cell carcinoma by IMP3 autoantibody [ Time Frame: Baseline ]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%).
- Presence of primary and/or metastatic renal cell carcinoma by miRNA/snRNA signature [ Time Frame: Baseline ]For the miRNA/snRNA signature study, the patients' clinical presentation of RCC and its recurrence/metastasis will be used as the golden standard to evaluate the sensitivity and specificity of the assay. Statistical significance will be set at P < 0.05 (confidence level of 95%).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806650
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Huiqing Wu, MD||City of Hope Medical Center|