Urothelial CarcinomaNCT06218433
Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
A study testing Urothelial cancer screening using urine tumor DNA test and Urothelial cancer screening using urine cytology (comparator) in people with Urothelial Carcinoma and Lynch Syndrome, run by Tampere University Hospital at 2 sites in 2 countries.
Trial summary
Lynch syndrome (LS) is an inherited cancer predisposition syndrome caused by pathogenic germline variants in DNA mismatch repair (MMR) genes. New cancer screening and diagnostic tools are urgently needed to identify LS-related cancers early enough for curative treatment. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Urothelial Carcinoma, Lynch Syndrome
- What is being tested?
- Urothelial cancer screening using urine tumor DNA test and Urothelial cancer screening using urine cytology (comparator)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Apr 2023to 31 Dec 2034
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent
- Diagnosis of Lynch syndrome
- Age 50 - 75 years at study recruitment
Who cannot join
- Concurrent urothelial carcinoma
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Canada1 site, 1 recruiting
- Recruiting
Vancouver Prostate Centre
Vancouver
Peter Black
Peter Black
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital and Tampere University
Tampere
Jussi Nikkola
Jussi Nikkola
About this study
Lynch syndrome (LS) is an inherited cancer predisposition syndrome caused by pathogenic germline variants in DNA mismatch repair (MMR) genes. New cancer screening and diagnostic tools are urgently needed to identify LS-related cancers early enough for curative treatment. Urothelial cancers (comprising bladder and upper tract urothelial tumors) are the third most common cancer after colorectal and endometrial cancers in individuals with LS. Up to one in four LS individuals will develop urothelial cancer during their lifetime, with the risk varying based on the defective MMR gene. In this clinical trial, we will employ urine tumor DNA (utDNA) to identify asymptomatic urothelial cancers in Lynch syndrome patients, and to investigate the potential benefits of urine tumor DNA based screening in this high-risk population.
- Conditions
- Urothelial Carcinoma, Lynch Syndrome
- Being tested
- Urothelial cancer screening using urine tumor DNA test, Urothelial cancer screening using urine cytology (comparator)
- Keywords
- Lynch syndrome, Hereditary cancer syndrome, Screening, Urothelial neoplasms, Bladder neoplasms, Upper tract urothelial neoplasms, Urogenital diseases, Liquid biopsies, Urine tumor DNA
- Medical subject headings
- Carcinoma, Transitional Cell, Colorectal Neoplasms, Hereditary Nonpolyposis, Neoplastic Syndromes, Hereditary, Urinary Bladder Neoplasms, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urothelial cancer screening using urine tumor DNA testDiagnostic test
Urine sample DNA is analyzed using a targeted sequencing panel encompassing the coding regions of 21 genes that are recurrently mutated in urothelial cancer
Urothelial cancer screening using urine cytology (comparator)Diagnostic test
Urine cytology sample
| Study group | Role | What they receive |
|---|---|---|
| Screening arm | Experimental | Invitation to participate in urothelial cancer screening and questionnaires Receives: Diagnostic Test: Urothelial cancer screening using urine tumor DNA test; Diagnostic Test: Urothelial cancer screening using urine cytology (comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of positive utDNA for urothelial cancer within one year of follow-up
Sensitivity and specificity of positive utDNA for urothelial cancer, using histologically verified cancers detected within 1 year of the utDNA test as ground truth
Measured: At 1 years of follow-up
Secondary outcomes (10)
Specificity of positive utDNA for urothelial cancer at the time of testing
Specificity of positive utDNA test for urothelial cancer, using histologically verified cancers detected in the cystoscopy and/or imaging performed due to positive utDNA test as the ground truth
Measured: After all patients with positive utDNA have been evaluated with cystoscopy and/or imaging
Sensitivity and specificity of positive utDNA for urothelial cancer within multiple years of follow-up
Sensitivity and specificity of positive utDNA for urothelial cancer, using histologically verified cancers detected within 2, 5, and 10 years of the utDNA test as ground truth
Measured: At 2, 5, and 10 years of follow-up
Overall survival
Overall survival in utDNA positive and negative patients
Measured: At 5 and 10 years of follow-up
Urothelial cancer specific survival
Urothelial cancer specific survival survival in utDNA positive and negative patients
Measured: At 3, 5 and 10 years of follow-up
Time to metastatic urothelial cancer
Time to metastatic urothelial cancer in utDNA positive and negative patients
Measured: At 5 and 10 years of follow-up
Time to diagnosis of muscle invasive or high grade urothelial cancer
Time to diagnosis of muscle invasive or high grade urothelial cancer in utDNA positive and negative patients
Measured: At 2, 5 and 10 years of follow-up
Time to diagnosis of urothelial cancer
Time to diagnosis of urothelial cancer in utDNA positive and negative patients
Measured: At 2, 5 and 10 years of follow-up
TNM pathological stage of urothelial cancers
TNM pathological stage (American Joint Committee on Cancer (AJCC)/International Union Against Cancer (UICC)) of urothelial cancers found in utDNA positive and negative patients
Measured: At 2, 5 and 10 years of follow-up
Size of urothelial tumors
Maximum diameter of urothelial tumors found in utDNA positive and negative patients
Measured: At 2, 5 and 10 years of follow-up
Urothelial cancer grade
The World Health Organization (WHO) 2004/2016 grading of urothelial cancers found in utDNA positive and negative patients
Measured: At 2, 5 and 10 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start10 Apr 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Jussi Nikkola, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218433
- Sponsor's protocol ID
- R22125
- Other IDs
- R22125
- Status last verified
- Nov 2025
- First submitted
- 10 Jan 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No