RECRUITING

Prospective Validation Study of High Volume Urine DNA Testing in Individuals with Suspicion of Urothelial Cancer

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

Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. Sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. Random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients.

Official Title

Observational Prospective Multicenter Validation Study Investigating the Possibility of Replacing Cystoscopies with High Volume Urine DNA Testing in Individuals with Suspicion of Urothelial Cancer (UROSCOUT-1)

Quick Facts

Study Start:2024-01-08
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06310759

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 to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide informed consent
  2. * Patient has been scheduled for cystoscopy to rule out urothelial cancer
  1. * Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)

Contacts and Locations

Study Contact

Jussi Nikkola, MD PhD
CONTACT
03311611
jussi.nikkola@fimnet.fi

Principal Investigator

Jussi Nikkola
PRINCIPAL_INVESTIGATOR
Tampere University Hospital

Study Locations (Sites)

Jesse Brown Department Of Veterans Affairs Medical Center
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: Tampere University Hospital

  • Jussi Nikkola, PRINCIPAL_INVESTIGATOR, Tampere University Hospital

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 Date2024-01-08
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2024-01-08
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

  • Urothelial neoplasms
  • Bladder neoplasms
  • Upper tract urothelial neoplasms
  • Liquid biopsies
  • Urine tumor DNA

Additional Relevant MeSH Terms

  • Urothelial Carcinoma