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Biomarker Discovery and Application in Bladder Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Wolfson Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962052
First Posted: August 19, 2009
Last Update Posted: September 14, 2010
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.
Collaborator:
Medical Diagnostic Laboratories, LLC
Information provided by:
Wolfson Medical Center
  Purpose

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
Bladder Cancer

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

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

Estimated Enrollment: 250
Study Start Date: July 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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).
Criteria

Inclusion Criteria:

  • Over 18 years old

Exclusion Criteria:

  • No exclusion criteria
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00962052


Contacts
Contact: Ami Sidi, Prof 972-3-5028653 sidi@wolfson.health.gov.il

Locations
Israel
Wolfson Medical Center Recruiting
Holon, Israel, 58100
Contact: Pnina Nir, Bsc    972-3-5028408    pninanir@wolfson.health.gov.il   
Principal Investigator: Ami Sidi, Prof         
Sponsors and Collaborators
Wolfson Medical Center
Medical Diagnostic Laboratories, LLC
  More Information

Responsible Party: Prof Ami Sidi, Wolfson M.C
ClinicalTrials.gov Identifier: NCT00962052     History of Changes
Other Study ID Numbers: MDL0806
First Submitted: August 18, 2009
First Posted: August 19, 2009
Last Update Posted: September 14, 2010
Last Verified: September 2010

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