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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Charles Rosser, MD; Phone Number: 310-423-5609; Email: Charles.Rosser@cshs.org

Study Locations

• Japan
  • Kyoto, Japan
    • Recruiting
    • Kyoto University Graduate School of Medicine
    • Contact: Yuki Kita, MD, PhD; Phone Number: +81-75-751-3337
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Amy Oppenheim; Phone Number: 310-423-3713; Email: Amy.Oppenheim@cshs.org
    • San Francisco, California, United States, 94158
      • Active, not recruiting
      • University of California San Francisco
  • Texas
    • Dallas, Texas, United States, 75390
      • Active, not recruiting
      • UT Southwestern Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance

Description

Inclusion Criteria

Participants must be:

• Age 18 years or older
• Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance
• Participants may be treated with adjuvant intravesical therapy
• Willing and able to give written informed consent (see Appendix 1)
• Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP22 BladderCheck.	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.	2 years

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Cancer Institute (NCI); University of California, San Francisco; Fred Hutchinson Cancer Center; University of Texas; Kyoto University; Nonagen Bioscience Corporation
• Investigators: Principal Investigator: Hideki Furuya, PhD, Cedars-Sinai Medical Center; Study Director: Charles Rosser, Nonagen Bioscience Corporation

Publications and helpful links

General Publications

• Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186/s12967-023-04811-2.
• Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. Res Sq [Preprint]. 2023 Nov 25:rs.3.rs-3635581. doi: 10.21203/rs.3.rs-3635581/v1.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2016
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: June 17, 2017
• First Submitted That Met QC Criteria: June 17, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: Rosser-2015-6; R01CA198887 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No