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

Recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT03193515
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Detailed Description

Not available

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: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Participants must not:

• 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

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.	2 years	To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a prospective longitudinal cohort of 300 participants with a history of BCa currently on cancer surveillance.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP22 BladderCheck.	2 years	To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort.; To develop a BCa risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.

Trial Locations

Locations (4)

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

University of California San Francisco; 🇺🇸 San Francisco, California, United States

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

Kyoto University Graduate School of Medicine; 🇯🇵 Kyoto, Japan