RECRUITING

CxBladder Surveillance of Intermediate and High-Risk Bladder Cancer Patients

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

Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective single arm multi-center study using the diagnostic CxBladder test with subjects previously diagnosed positive with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of urothelial carcinoma presenting to qualified sites. To test the pathway multiple consecutive urine samples will be collected during the course of surveillance and records review follow-up will also be completed.

Official Title

An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Intermediate and High-Risk Patients

Quick Facts

Study Start:2022-06-08
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05080998

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. High and intermediate risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma
  2. 2. Subjects must agree to 4 successive visits including urine sample collection at each of the study visits and records review follow-up
  3. 3. Able to provide a voided urine sample (a sample from catheterization is not eligible) of the required minimum volume
  4. 4. Able to give written consent
  5. 5. Able and willing to comply with study requirements
  6. 6. Aged 18 years or older
  1. 1. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterization, urethral dilation) in the 14 days before urine collection
  2. 2. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
  3. 3. Previous muscle invasive bladder tumour (pT2 or greater)
  4. 4. Pregnancy

Contacts and Locations

Study Contact

Alexis White, BSc (Hons)
CONTACT
+64 21 959 001
alexis.white@pacificedgedx.com
Anke Fronius
CONTACT
+64 27 839 3164
anke.fronius@pelnz.com

Principal Investigator

Tony Lough
STUDY_CHAIR
Pacific Edge Pty Ltd

Study Locations (Sites)

White River Junction Veterans Affair Medical Center
White River Junction, Vermont, 05009
United States
University of Washington School of Medicine
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Pacific Edge Limited

  • Tony Lough, STUDY_CHAIR, Pacific Edge Pty Ltd

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 Date2022-06-08
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-06-08
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Urothelial Bladder Cancer