RECRUITING

Longitudinal Bladder Cancer Study for Tumour Recurrence

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 with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characterisitc of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.

Official Title

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

Quick Facts

Study Start:2022-06-08
Study Completion:2026-08-31
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. Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.
  2. 2. Subjects must agree to 4 successive study visits, including urine sample collection at each visit.
  3. 3. Physically able to provide a voided urine sample (a sample from catheterization is not eligible).
  4. 4. Able to give written informed consent
  5. 5. Able and willing to comply with study requirements
  6. 6. Aged 18 years or older
  1. 1. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
  2. 2. Previous muscle invasive bladder tumour (pT2 or greater)
  3. 3. Known pregnancy
  4. 1. Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed.
  5. 2. Active urinary tract infection (UTI) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until the treatment is complete and the UTI is resolved.
  6. 3. If a subject has had intravesical immunotherapy or chemotherapy within the previous 6 weeks, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred. Study enrollment must be at least 28 calendar days post-last treatment.

Contacts and Locations

Study Contact

Donna Smith, MSc (Hons)
CONTACT
+64 21 243 6696
donna.smith@pacificedgedx.com
Alexis White
CONTACT
+64 21 959 001
alexis.white@pelnz.com

Principal Investigator

Tony Lough
STUDY_CHAIR
Pacific Edge Pty Ltd

Study Locations (Sites)

Miami VA Healthcare System
Miami, Florida, 33125
United States
James A. Haley Veteran's Hospital
Tampa, Florida, 33612
United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, 29401
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
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 Date2026-08-31

Study Record Updates

Study Start Date2022-06-08
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • Recurrence

Additional Relevant MeSH Terms

  • Urothelial Bladder Cancer