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Trial Title:
Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
NCT ID:
NCT06126796
Condition:
Non-muscle Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CxBladder Monitor
Description:
CxBladder Monitor (CxbM) is an FDA-approved genomic biomarker test specifically designed
for patients undergoing surveillance for NMIBC. The non-invasive urine test quantifies 5
measured biomarker genes (MDK, HOXA13, CDC2 (CDK1), IGFBP5, CXCR2) and incorporates this
information into an algorithm to detect the presence or absence of bladder cancer.
Arm group label:
Arm A: CxBladder followed by cystoscopy
Arm group label:
Arm B: cystoscopy followed by CxBladder
Other name:
CxBladder
Other name:
CxbM
Intervention type:
Diagnostic Test
Intervention name:
Cystoscopy
Description:
Cystoscopy is the most common way surveillance has been performed for NMIBC. Cystoscopy
is a procedure that allows your doctor to examine the lining of your bladder and the tube
that carries urine out of your body (urethra). A hollow tube (cystoscope) equipped with a
lens is inserted into your urethra and slowly advanced into your bladder.
Arm group label:
Arm A: CxBladder followed by cystoscopy
Arm group label:
Arm B: cystoscopy followed by CxBladder
Summary:
The purpose of this study is to evaluate patient-reported preference for urine based
molecular testing (CxBladder Monitor) compared to cystoscopy for patients on surveillance
for Nonmuscle Invasive Bladder Cancer (NMIBC). Urine based molecular testing involves
noninvasive testing of a urine sample for biomarkers associated with disease recurrence.
Cystoscopy is an examination of the bladder and urethra using a thin tube like instrument
that is inserted into the urethra.
Criteria for eligibility:
Study pop:
Male or female adult patients who are undergoing cystoscopic surveillance for NMIBC after
at least 9 months of recurrence-free survival.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Male or female with a history of histologically confirmed nonmuscle invasive bladder
cancer (NMIBC) who have at least 6 months of disease-free survival from last
recurrence.
- Able to provide urine for testing and comply with study protocol.
- Have an email address and be willing to complete surveys online.
Exclusion Criteria:
- History of non-urothelial bladder cancer (primary squamous, adenocarcinoma, and
small cell carcinoma)
- Patients with predominant (>50%) variant histology
- Patients with a history of upper tract and/or urethral cancer
- Women who are pregnant
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Mark D. Tyson, M.D., M.P.H.
Email:
Principal Investigator
Start date:
November 16, 2023
Completion date:
November 2024
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06126796
https://www.mayo.edu/research/clinical-trials
