A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer

Description

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

Conditions

Bladder Cancer

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Study Overview

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Study Details

Study overview

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer

A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer

Condition
Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

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

Los Angeles

University of California Los Angeles, Los Angeles, California, United States, 90095

Rochester

University of Rochester Medical Center, Rochester, New York, United States, 14627

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

  • * Age 18 years or older
  • * Have documented or reported gross hematuria within 3 month of study enrollment
  • * Willing and able to give written informed consent
  • * Have history of BCa
  • * History of previous cancer (excluding 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 hematuria evaluation (i.e., cystoscopy and upper tract imaging)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cedars-Sinai Medical Center,

Charles Rosser, MD, STUDY_DIRECTOR, Nonagen Bioscience Corporation

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

Study Record Dates

2025-12-30