RECRUITING

Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance

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 purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing. Specifically, this study examines whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.

Official Title

Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance

Quick Facts

Study Start:2023-11-17
Study Completion:2028-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05796375

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. Aged 18 years or older
  2. 2. History of low grade intermediate-risk non-muscle invasive bladder cancer, defined as most recent pathology report showing any of the following:
  3. * multifocal low grade non-invasive urothelial carcinoma of any size
  4. * solitary low grade non-invasive urothelial carcinoma greater than 3cm in size
  5. * recurrent low grade non-invasive urothelial carcinoma
  6. 3. Stated willingness to comply with all study procedures and availability for the duration of the study
  7. 4. No evidence for recurrence at cystoscopy ≤4 months after most recent tumor resection
  8. 5. Ability to consent in English or Spanish
  1. 1. History of total cystectomy of the bladder.
  2. 2. History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit).
  3. 3. History of muscle-invasive bladder tumor.
  4. 4. Pregnancy or lactation.
  5. 5. History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of recurrent upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion)
  6. 6. Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).
  7. 7. Inability to provide a voided urine sample.

Contacts and Locations

Study Contact

Florian R Schroeck, MD, MS
CONTACT
802-295-9363
florian.schroeck@va.gov
Laura Jensen, MPH
CONTACT
802-280-5298
Laura.Jensen@va.gov

Principal Investigator

Florian R Schroeck, MD, MS
PRINCIPAL_INVESTIGATOR
White River Junction VA Healthcare System

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States
UT Southwestern Medical Center
Dallas, Texas, 75235
United States
White River Junction Veterans Healthcare System
White River Junction, Vermont, 05009
United States

Collaborators and Investigators

Sponsor: White River Junction Veterans Affairs Medical Center

  • Florian R Schroeck, MD, MS, PRINCIPAL_INVESTIGATOR, White River Junction VA Healthcare System

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 Date2023-11-17
Study Completion Date2028-12-30

Study Record Updates

Study Start Date2023-11-17
Study Completion Date2028-12-30

Terms related to this study

Keywords Provided by Researchers

  • Bladder
  • Cancer
  • Urology
  • Cystoscopy
  • Xpert
  • EpiCheck
  • Urine test

Additional Relevant MeSH Terms

  • Non-muscle-invasive Bladder Cancer