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A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

NCT03193515 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-02-04

No results posted yet for this study

Summary

Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.

Conditions

Sponsors & Collaborators

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • University of California, San Francisco

    collaborator OTHER

  • Nonagen Bioscience Corporation

    collaborator INDUSTRY

  • Kyoto University

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Hideki Furuya, PhD · Cedars-Sinai Medical Center

  • Charles Rosser · Nonagen Bioscience Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-30
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • United States
  • Japan

Study Locations

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Entities

Diseases
Companies

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 NCT03193515 on ClinicalTrials.gov