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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.

• Subjects must agree to 4 successive study visits, including urine sample collection at each visit.

• Physically able to provide a voided urine sample (a sample from catheterization is not eligible).

• Able to give written informed consent

• Able and willing to comply with study requirements

• Aged 18 years or older

Locations
United States
Florida
Miami VA Healthcare System
RECRUITING
Miami
James A. Haley Veteran's Hospital
RECRUITING
Tampa
South Carolina
Ralph H. Johnson VA Health Care System
RECRUITING
Charleston
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Vermont
White River Junction Veterans Affair Medical Center
RECRUITING
White River Junction
Washington
University of Washington School of Medicine
RECRUITING
Seattle
Other Locations
Australia
Monash Health - Moorabbin Hospital
RECRUITING
Clayton
Contact Information
Primary
Donna Smith, MSc (Hons)
donna.smith@pacificedgedx.com
+64 21 243 6696
Backup
Alexis White
alexis.white@pelnz.com
+64 21 959 001
Time Frame
Start Date: 2022-06-08
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 450
Treatments
Single arm - Patients undergoing surveillance for UC recurrence
Subjects previously diagnosed with UC and are undergoing a schedule of surveillance cystoscopies and treatment for the possible recurrence of UC will be recruited. Low-, intermediate-, and high-risk groups, according to AUA /SUO risk categorisation for non-muscle invasive UC, will be eligible for this study. All subjects will undergo CxBladder urine diagnostic testing.
Sponsors
Leads: Pacific Edge Limited

This content was sourced from clinicaltrials.gov