Biomarker Discovery and Application in Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT00962052|
Recruitment Status : Unknown
Verified September 2010 by Wolfson Medical Center.
Recruitment status was: Recruiting
First Posted : August 19, 2009
Last Update Posted : September 14, 2010
The investigators' long-term objective is to research and develop innovative new tests which diagnostic laboratories can use to 1) detect methylated DNA targets, 2) tumor specific antigens, and 3) markers of Bacillus Calmette-Guerin (BCG) treatment in patient urine samples. The investigators plan to detect methylated DNA targets and control targets by methylation-specific polymerase chain reaction (msPCR) on DNA isolated from urine samples from bladder cancer positive and negative patients to determine its sensitivity and specificity in detecting bladder cancer. The investigators plan to use patient sera as a tool to detect tumor specific antigens expressed by bladder cancer cell lines. Once a bladder tumor specific protein is identified, the investigators will assess its presence in the urine of bladder cancer patients and absence in healthy patients by enzyme-linked immunosorbent assay (ELISA). The investigators plan to use both in vitro models and patient clinical samples to elucidate the role of bladder epithelial cells in mediating BCG immunotherapy and identify biomarkers of treatment effectiveness. Once a biomarker is identified, the investigators will assess its presence in the urine of bladder cancer and absence in healthy patients.
Once the investigators determine the feasibility of these tests, the investigators will further perform an extensive clinical study, comparing the tests to existing diagnostic methods. This study will provide the foundation for FDA approval, which is required for tests to become widely accepted tools for clinicians to use in bladder cancer diagnosis. The investigators' tests will improve early detection of bladder cancer, thereby improving patient health and decrease cancer deaths, a key mission of the National Institutes of Health.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Biomarker Discovery and Application in Bladder Cancer: Identification and Detection of Gene Methylation, Tumor Specific Antigenes Markers of BCG Treatment.|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2011|
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): NCT00962052
|Contact: Ami Sidi, Proffirstname.lastname@example.org|
|Wolfson Medical Center||Recruiting|
|Holon, Israel, 58100|
|Contact: Pnina Nir, Bsc 972-3-5028408 email@example.com|
|Principal Investigator: Ami Sidi, Prof|