None listed
Conditions
Brief summary
The aim is to determine whether Cxbladder is as accurate as cystoscopy current technologies in determining freedom from, or recurrence of cancer in the group of patients having undergone Bacillus Calmette-Guerin (BCG) immunotherapy or Mitomycin C intravesical chemotherapy for transitional cell carcinoma of the bladder. This study aims to investigate the diagnostic test accuracy of Cxbladder for predicting recurrence of cancer in the group of patients having undergone Bacillus Calmette-Guerin immunotherapy or Mitomycin C intravesical chemotherapy for transitional cell carcinoma of the bladder.. Who is it for? You may be eligible to join this study if you are aged between 18 and 85 years undergoing Bacillus Calmette-Guerin therapy or Mitomycin C therapy for bladder cancer or DMSO/heparin therapy for painful bladder syndrome at Concord Hospital. Study details All participants of this study will provide urine samples before they commence treatment and then at 1, 2, 3 and 6 months and one additional timepoint 1-3 years following completion of treatment. These samples will be analysed using Cxbladder diagnostic test and results then compared with currently used cystoscopy exam results. These findings will not be used in treatment decisions but will help establish if Cxbladder test can be used to predict cancer recurrence in patients undergoing this type of treatment.
Interventions
The aim is to determine whether Cxbladder, a urine diagnostic test is as accurate as cystoscopy current technologies in determining freedom from, or recurrence of cancer in the a group of patients having undergone BCG immunotherapy or Mitomycin C intravesical chemotherapy for transitional cell carcinoma of the bladder.
Hypothesis: The Cxbladder test is accurate at predicting the recurrence status of bladder cancer in patients who have undergone intra-vesical therapy.
Patients are required to p
The aim is to determine whether Cxbladder, a urine diagnostic test is as accurate as cystoscopy current technologies in determining freedom from, or recurrence of cancer in the a group of patients having undergone BCG immunotherapy or Mitomycin C intravesical chemotherapy for transitional cell carcinoma of the bladder. Hypothesis: The Cxbladder test is accurate at predicting the recurrence status of bladder cancer in patients who have undergone intra-vesical therapy. Patients are required to provide samples prior to treatment and then at 1,2,3,6 months and one additional timepoint (1-3 years) following BCG or MCC treatment. Samples are analysed and gene expression scores determined – however no sites are provided with direct patient scores. The study is observational only and results are only provided to the site after the study is closed and for the purpose of collating data for publication. Samples are analysed and gene expression scores are determined as (but not provided to site) 1) Normal <0.12 2) Elevated 0.12-0.23 3) High >0.23 (Positive Predictive Value (PPV) of 68%. High probability of urothelial carcinoma)
Sponsors
Pacific Edge Diagnostics Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Men and women between 18 and 85 years undergoing BCG or Mitomycin C (MMC) therapy for urothelial carcinoma or DMSO/heparin therapy for painful bladder syndrome at Concord Hospital. The study invites patients undergoing DMSO/heparin therapy as a control group - The Cxbladder results from these patients are compared against those for the BCG or Mitomycin C (MMC) therapy patients.
Exclusion criteria
Patients declining involvement in the study and patients with obvious active urinary tract infections.
Outcome results
None listed