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Biomarker Discovery and Application in Bladder Cancer

NCT ID: NCT00962052

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Over 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Diagnostic Laboratories, LLC

INDUSTRY

Sponsor Role collaborator

Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wolfson M.C

Locations

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Wolfson Medical Center

Holon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ami Sidi, Prof

Role: CONTACT

[email protected]
972-3-5028653

Facility Contacts

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Pnina Nir, Bsc

Role: primary

[email protected]
972-3-5028408

Other Identifiers

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MDL0806

Identifier Type: -

Identifier Source: org_study_id