What this study is
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 details
- Sponsor
- Cedars-Sinai Medical Center
- Conditions
- Bladder Cancer
- Enrolling
- 300 people
- Starts
- 2016-12-30
- Est. completion
- 2028-08
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
2 openCedars-Sinai Medical Center
Los Angeles, California, United States
- Amy Oppenheim · Contact310-423-3713Amy.Oppenheim@cshs.org
RecruitingUniversity of California San Francisco
San Francisco, California, United States
Active, not recruitingUT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Active, not recruiting
1 site outside the US
- Recruiting
Study team
Sponsor
Cedars-Sinai Medical Center
Study ID Rosser-2015-6
Principal investigator
Hideki Furuya, PhD
Cedars-Sinai Medical Center
Study director
Charles Rosser
Nonagen Bioscience Corporation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.