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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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00962052
Enrollment
250
Registered
2009-08-19
Start date
2009-07-31
Completion date
2011-12-31
Last updated
2010-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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.

Interventions

None listed

Sponsors

Medical Diagnostic Laboratories, LLC
CollaboratorINDUSTRY
Wolfson Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Over 18 years old

Exclusion criteria

* No

Countries

Israel

Contacts

Primary ContactAmi Sidi, Prof
sidi@wolfson.health.gov.il972-3-5028653

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026