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NCT06218433
Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
NA trial testing Urothelial cancer screening using urine tumor DNA test in Urothelial Carcinoma in 200 participants. Currently enrolling.
30 December 2026
Quick facts
| Lead sponsor | Tampere University Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 200 |
| Start date | 10 April 2023 |
| Primary completion | 30 December 2026 |
| Estimated completion | 31 December 2034 |
| Sites | 2 locations across Finland, Canada |
Drugs / interventions tested
- Urothelial cancer screening using urine tumor DNA test
- Urothelial cancer screening using urine cytology (comparator)
Conditions studied
- Urothelial Carcinoma — all drugs for Urothelial Carcinoma →
- Lynch Syndrome — all drugs for Lynch Syndrome →
Sponsor
Tampere University Hospital
Who can join
Adults 50 to 75, any sex, with Urothelial Carcinoma or Lynch Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Clinical Implications of the Molecular and Genomic Landscape of Upper Tract Urothelial Carcinoma.
Jaime-Casas S, Tripathi A, Pal SK, Yip W. · · 2024 · cited 6× · PMID 39379745 · DOI 10.1007/s11934-024-01245-1 -
Clinical Applications of Liquid Biopsy in Colorectal Cancer: A Focus on Registered Clinical Trials.
Garcia-Pelaez J, Yáñez Y, Aupí M, Lázaro M, et al · · 2026 · PMID 42194957 · DOI 10.3390/genes17050500 -
Abstracts selected for poster presentation [listed in alphabetical order by presenter].
· 2026 · PMID 41625014 · DOI 10.1177/23523735251412131
Verify or expand the search:
- PubMed search for NCT06218433
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07492628 — Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma · Phase 1 · recruiting
- NCT07390617 — A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06218433 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tampere University Hospital
- Last refreshed: 18 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06218433.
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