RECRUITING

A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

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Conditions

Bladder CancerNon-muscle invasive bladder cancerMCM5BiomarkerUrinary biomarkerFollow-upSurveillance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2021-07-01
Study Completion:2023-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05508568

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Patients 22 years of age or older
  3. * Patients who, in the opinion of the Investigator, are suitable for standard urological investigations as part of normal clinical practice
  4. * Patients who are, in the opinion of the Investigator, able to understand the purpose of the study and provide a full void urine specimen
  5. * Patients who are able to give voluntary, written informed consent to participate in this study
  1. * Patients with known active (symptomatic) calculi within the urino-genitary system
  2. * Patients who provide less than 10mL of full void urine
  3. * Patients undergoing active treatment for interstitial cystitis
  4. * Patients currently undergoing systemic chemotherapy or systemic immunotherapy or radiotherapy. Intravesical chemotherapy or immunotherapy (BCG) is allowed
  5. * 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
  6. * Patients who have had urological instrumentation to the urinary tract within 14 days prior to the test
  7. * Male patients undergoing active treatment for prostatitis

Contacts and Locations

Study Contact

Jacqueline Stockley, PhD
CONTACT
+44 191 516 6764
jacqui@arquerdx.com

Principal Investigator

Professor Ashish Kamat
PRINCIPAL_INVESTIGATOR
The University of Texas MD Anderson Cancer Center

Study Locations (Sites)

The Urology Center of Colorado
Denver, Colorado, 80211
United States
Advanced Urology Institute
Daytona Beach, Florida, 32114
United States
First Urology
Jeffersonville, Indiana, 47130
United States
Michigan Institute of Urology
Troy, Michigan, 48084
United States
New Jersey Urology
Mount Laurel, New Jersey, 08054
United States
Associated Medical Professionals of NY
Syracuse, New York, 13210
United States
Clinical Research Solutions
Cleveland, Ohio, 44130
United States
MidLantic Urology
Philadelphia, Pennsylvania, 19004
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
United States
Urology San Antonio
San Antonio, Texas, 78229
United States
Virginia Urology Center
Richmond, Virginia, 23235
United States
Urology of Virginia
Virginia Beach, Virginia, 23462
United States
Spokane Urology
Spokane, Washington, 99202
United States

Collaborators and Investigators

Sponsor: Arquer Diagnostics Ltd

  • Professor Ashish Kamat, PRINCIPAL_INVESTIGATOR, The University of Texas MD Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01
Study Completion Date2023-04

Study Record Updates

Study Start Date2021-07-01
Study Completion Date2023-04

Terms related to this study

Keywords Provided by Researchers

  • Bladder Cancer
  • Non-muscle invasive bladder cancer
  • MCM5
  • Biomarker
  • Urinary biomarker
  • Follow-up
  • Surveillance

Additional Relevant MeSH Terms

  • Bladder Cancer