Trial Title:
A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
NCT ID:
NCT05508568
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Recurrence
Conditions: Keywords:
Bladder Cancer
Non-muscle invasive bladder cancer
MCM5
Biomarker
Urinary biomarker
Follow-up
Surveillance
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
ADXBLADDER
Description:
ADXBLADDER is a non-invasive, qualitative ELISA utilising a combination of two monoclonal
antibodies for the detection of MCM5 in urine sediment. It is intended to aid in the
monitoring of bladder cancer recurrence in non-muscle-invasive bladder cancer patients.
Participants will be asked to provide a full void urine specimen, which will be
centrifuged before the urine sediment is lysed. The lysed sample will then be tested with
ADXBLADDER.
Arm group label:
Non-muscle invasive bladder cancer patients in follow-up
Summary:
The objective of this prospective, multi-centre study is to evaluate the performance of
ADXBLADDER, a urine MCM5 ELISA test, as an aid in the detection of bladder cancer
recurrence. Patients undergoing cystoscopic surveillance in non-muscle invasive bladder
cancer (NMIBC) follow-up will be recruited and asked to provide a urine sample to be
tested with ADXBLADDER. To assess the diagnostic accuracy of the test, the MCM5 results
will be compared with the gold standard cystoscopy and pathology of resected tissue.
Criteria for eligibility:
Study pop:
Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer
(NMIBC) follow-up.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients who have been diagnosed with NMIBC in the previous 2 years, and are
attending the urology clinic for standard of care/routine monitoring cystoscopy
- Patients 22 years of age or older
- Patients who, in the opinion of the Investigator, are suitable for standard
urological investigations as part of normal clinical practice
- Patients who are, in the opinion of the Investigator, able to understand the purpose
of the study and provide a full void urine specimen
- Patients who are able to give voluntary, written informed consent to participate in
this study
Exclusion Criteria:
- Patients with known active (symptomatic) calculi within the urino-genitary system
- Patients who provide less than 10mL of full void urine
- Patients undergoing active treatment for interstitial cystitis
- Patients currently undergoing systemic chemotherapy or systemic immunotherapy or
radiotherapy. Intravesical chemotherapy or immunotherapy (BCG) is allowed
- Patients who have previously been diagnosed with renal cancer, prostate cancer,
Muscle Invasive Bladder cancer, an upper tract tumour, or CiS in the prostatic
urethra
- Patients who have had urological instrumentation to the urinary tract within 14 days
prior to the test
- Male patients undergoing active treatment for prostatitis
Gender:
All
Minimum age:
22 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Urology Center of Colorado
Address:
City:
Denver
Zip:
80211
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Larry Karsh, MD
Email:
Principal Investigator
Facility:
Name:
Advanced Urology Institute
Address:
City:
Daytona Beach
Zip:
32114
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Martin K. Deneen, MD
Email:
Principal Investigator
Facility:
Name:
First Urology
Address:
City:
Jeffersonville
Zip:
47130
Country:
United States
Status:
Recruiting
Investigator:
Last name:
James Bailen, MD
Email:
Principal Investigator
Facility:
Name:
Michigan Institute of Urology
Address:
City:
Troy
Zip:
48084
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jason Hafron, MD
Email:
Principal Investigator
Facility:
Name:
New Jersey Urology
Address:
City:
Mount Laurel
Zip:
08054
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Louis Keeler, MD
Email:
Principal Investigator
Facility:
Name:
Associated Medical Professionals of NY
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Christopher Pieczonka, MD
Email:
Principal Investigator
Facility:
Name:
Clinical Research Solutions
Address:
City:
Cleveland
Zip:
44130
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Lawrence A. Gervasi, MD
Email:
Principal Investigator
Facility:
Name:
MidLantic Urology
Address:
City:
Philadelphia
Zip:
19004
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Laurence Belkoff, MD
Email:
Principal Investigator
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Neal Shore, MD
Email:
Principal Investigator
Facility:
Name:
Urology San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jose De La Cerda, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Urology Center
Address:
City:
Richmond
Zip:
23235
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Eugene Kramolowsky, MD
Email:
Principal Investigator
Facility:
Name:
Urology of Virginia
Address:
City:
Virginia Beach
Zip:
23462
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Michael Williams, MD
Email:
Principal Investigator
Facility:
Name:
Spokane Urology
Address:
City:
Spokane
Zip:
99202
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Raymond Lance, MD
Email:
Principal Investigator
Start date:
July 1, 2021
Completion date:
April 2023
Lead sponsor:
Agency:
Arquer Diagnostics Ltd
Agency class:
Industry
Source:
Arquer Diagnostics Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05508568
