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

Recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT03193541
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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 microscopic hematuria.

Detailed Description

Hematuria is the most common presentation of BCa with 8% of patients with microscopic 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 will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder.

We propose to improve 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 microscopic hematuria.

Study Timeline

• Study Start: 2016-12-30
• Study First Submitted: 2017-06-17
• Study First Submitted QC: 2017-06-17
• Study First Posted: 2017-06-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-29
• Primary Completion: 2027-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Age 18 years or older
• Have documented or reported microscopic hematuria within 3 month of study enrollment
• Willing and able to give written informed consent

Exclusion Criteria (participants must not):

• Have history of BCa
• History of previous cancer (excluding basal and squamous cell skin cancer)
• 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)
• 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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.	1 year

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.	1 year

Trial Locations

Locations (7)

VA Long Beach Healthcare System; 🇺🇸 Long Beach, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

UT Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

Nara Prefecture Seiwa Medical Center; 🇯🇵 Nara, Japan

Nara Medical University; 🇯🇵 Nara, Japan