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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03193515

Enrollment

300

Registered

2017-06-20

Start date

2016-12-30

Completion date

2028-08-01

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Japan, United States

Contacts

CONTACTCharles Rosser, MD

Charles.Rosser@cshs.org310-423-5609

PRINCIPAL_INVESTIGATORHideki Furuya, PhD

Cedars-Sinai Medical Center

STUDY_DIRECTORCharles Rosser

Nonagen Bioscience Corporation

Outcome results