A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
2 other identifiers
observational
300
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 30, 2016
CompletedFirst Submitted
Initial submission to the registry
June 17, 2017
CompletedFirst Posted
Study publicly available on registry
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
February 4, 2026
February 1, 2026
11.6 years
June 17, 2017
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP22 BladderCheck.
2 years
Eligibility Criteria
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
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cedars-Sinai Medical Centerlead
- University of Texascollaborator
- Fred Hutchinson Cancer Centercollaborator
- University of California, San Franciscocollaborator
- Nonagen Bioscience Corporationcollaborator
- Kyoto Universitycollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (4)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California San Francisco
San Francisco, California, 94158, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Kyoto University Graduate School of Medicine
Kyoto, Japan
Related Publications (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. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186/s12967-023-04811-2.
PMID: 38167321DERIVEDFuruya 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.
PMID: 38045238DERIVED
Biospecimen
Urine collection (minimal 50 mL) and cystoscopy (+ biopsy w/in 4 weeks, if abnormal noted)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hideki Furuya, PhD
Cedars-Sinai Medical Center
- STUDY DIRECTOR
Charles Rosser
Nonagen Bioscience Corporation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 17, 2017
First Posted
June 20, 2017
Study Start
December 30, 2016
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
February 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share