Bladder Cancer Clinical Trial

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

Summary

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.

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Full Description

Hematuria is the most common presentation of BCa with 22% of patients with gross hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable.

Because of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose 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.

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Eligibility Criteria

Inclusion 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

Exclusion Criteria (patients must not):

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)

Study is for people with:

Bladder Cancer

Estimated Enrollment:

450

Study ID:

NCT03193528

Recruitment Status:

Recruiting

Sponsor:

Cedars-Sinai Medical Center

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There are 3 Locations for this study

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Cedars-Sinai Medical Center
Los Angeles California, 90048, United States More Info
Amy Oppenheim
Contact
310-423-3713
[email protected]
University of California Los Angeles
Los Angeles California, 90095, United States More Info
Arnold Chin, MD, PhD
Contact
UT Southwestern Medical Center at Dallas
Dallas Texas, 75390, United States More Info
Yair Lotan
Contact
214-648-0389
[email protected]
Department of Urology, Nara Medical University
Nara , , Japan More Info
Satoshi Anai
Contact
+81-744-22-3051
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

450

Study ID:

NCT03193528

Recruitment Status:

Recruiting

Sponsor:


Cedars-Sinai Medical Center

How clear is this clinincal trial information?

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