A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
NCT ID: NCT03193515
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
300 participants
OBSERVATIONAL
2016-12-30
2028-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
NCT03193541
A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
NCT03193528
A Diagnostic for the Early Detection of Bladder Cancer
NCT05347342
The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma
NCT02700464
Study of Combined VisioCyt Test and FGFR3 Mutations on a Urinary Sample to Diagnose Bladder Tumors
NCT05151341
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fred Hutchinson Cancer Center
OTHER
University of Texas
OTHER
University of California, San Francisco
OTHER
Nonagen Bioscience Corporation
INDUSTRY
Kyoto University
OTHER
National Cancer Institute (NCI)
NIH
Cedars-Sinai Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Charles Rosser
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hideki Furuya, PhD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Charles Rosser
Role: STUDY_DIRECTOR
Nonagen Bioscience Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yuki Kita, MD, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Rosser-2015-6
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.