NCT03193515 A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
| NCT ID | NCT03193515 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2016-12-30 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2016-12-30 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Hideki Furuya, PhD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT03193515 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03193515 currently recruiting?
Yes, NCT03193515 is actively recruiting participants. Contact the research team at Charles.Rosser@cshs.org for enrollment information.
Where is the NCT03193515 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Francisco, United States, Dallas, United States, Kyoto, Japan.
Who is sponsoring the NCT03193515 clinical trial?
NCT03193515 is sponsored by Cedars-Sinai Medical Center. The principal investigator is Hideki Furuya, PhD at Cedars-Sinai Medical Center. The trial plans to enroll 300 participants.
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