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

Description

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

Bladder Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

San Francisco

University of California San Francisco, San Francisco, California, United States, 94158

Dallas

UT Southwestern Medical Center at Dallas, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have had radical cystectomy
  • * History of previous cancer (excluding bladder, basal and squamous cell skin cancer) within the past 3 years
  • * Have a known active urinary tract infection or urinary retention
  • * Have active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 60 days before consent, otherwise repeat.
  • * Have ureteral stents, nephrostomy tubes or bowel interposition
  • * Have recent genitourinary instrumentation (within 10 days prior to signing consent)
  • * Be unable or unwilling to complete the surveillance regimen

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cedars-Sinai Medical Center,

Hideki Furuya, PhD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Charles Rosser, STUDY_DIRECTOR, Nonagen Bioscience Corporation

Study Record Dates

2026-02