Biomarker Discovery and Application in Bladder Cancer

Biomarker Discovery and Application in Bladder Cancer: Identification and Detection of Gene Methylation, Tumor Specific Antigenes Markers of BCG Treatment.

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Ami Sidi, Prof; Phone Number: 972-3-5028653; Email: sidi@wolfson.health.gov.il

Study Locations

• Israel
  • Holon, Israel, 58100
    • Recruiting
    • Wolfson Medical Center
    • Contact: Pnina Nir, Bsc; Phone Number: 972-3-5028408; Email: pninanir@wolfson.health.gov.il
    • Principal Investigator: Ami Sidi, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

• Over 18 years old

Exclusion Criteria:

• No exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Collaborators: Medical Diagnostic Laboratories, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: August 18, 2009
• First Submitted That Met QC Criteria: August 18, 2009
• First Posted (Estimate): August 19, 2009

Study Record Updates

• Last Update Posted (Estimate): September 14, 2010
• Last Update Submitted That Met QC Criteria: September 12, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: MDL0806