Biomarker Discovery and Application in Bladder 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. 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
Medical Diagnostic Laboratories, LLC
Information provided by:
Wolfson Medical Center

Brief Summary:

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
Bladder Cancer

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Biospecimen Retention:   Samples With DNA
blood, first void urine, bladder tumors and healthy tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. Those currently diagnosed and undergoing treatment for bladder cancer (100).
  2. Those currently diagnosed with other urogenital cancers including prostate cancer and kidney cancer (50).
  3. Those currently diagnosed with non-malignant urogenital conditions including urinary tract infection, interstitial cystitis, and kidney stones for specificity analysis (50).
  4. Healthy control patients (50).

Inclusion Criteria:

  • Over 18 years old

Exclusion Criteria:

  • No exclusion criteria

Information from the National Library of Medicine

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 identifier (NCT number): NCT00962052

Contact: Ami Sidi, Prof 972-3-5028653

Wolfson Medical Center Recruiting
Holon, Israel, 58100
Contact: Pnina Nir, Bsc    972-3-5028408   
Principal Investigator: Ami Sidi, Prof         
Sponsors and Collaborators
Wolfson Medical Center
Medical Diagnostic Laboratories, LLC

Responsible Party: Prof Ami Sidi, Wolfson M.C Identifier: NCT00962052     History of Changes
Other Study ID Numbers: MDL0806
First Posted: August 19, 2009    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases