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Urinary Biomarkers in the Detection of Urothelial Carcinoma of the Bladder

NCT02745301 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2018-08-13

No results posted yet for this study

Summary

To assess the persistence of bladder cancer-specific biomarkers in urine collected pre-operatively, in resected cancer tissue, and in urine collected post-operatively. A panel of sensitive and specific bladder cancer biomarkers will be used to establish a signature of disease in pre-operative patients with a positive diagnosis for bladder cancer by current standard of care (e.g., in-office cystoscopy, OR cystoscopy). The specificity of these markers will be assessed, as well as the degree of non-specific signal attributable to other sources of biomolecules, by analyzing resected tumor tissue for the same biomarkers. Finally, post-operative urine will be assessed for the presence of these markers. To the extent this biomarker panel can be determined to be specific and sensitive, it may serve as an indicator of the degree to which the surgical intervention successfully eradicated the underlying disease. The investigators also aim to assess the stability of a biomarker signature in urine but evaluating several patient specimens over various time points throughout the day.

Conditions

  • Bladder Cancer, Biomarkers

Interventions

OTHER

Collection of urine and bladder tumor specimens

Voided urine (pre- and post surgical) and intraoperative bladder tumor specimens to be processed for the presence of specific biomarkers.

Sponsors & Collaborators

  • Element Diagnostics

    collaborator UNKNOWN

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Kristen R Scarpato, MD · Vanderbilt University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02745301 on ClinicalTrials.gov