Clinical trial · Interventional
Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lynch Syndrome | — | UNRESOLVED | — |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Urothelial cancer screening using urine cytology (comparator) | Diagnostic Test | — | UNRESOLVED |
| Urothelial cancer screening using urine tumor DNA test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening arm
- description
- Invitation to participate in urothelial cancer screening and questionnaires
- interventionNames
- Diagnostic Test: Urothelial cancer screening using urine tumor DNA test
- Diagnostic Test: Urothelial cancer screening using urine cytology (comparator)
Primary outcomes (1)
- measure
- Sensitivity and specificity of positive utDNA for urothelial cancer within one year of follow-up
- timeFrame
- At 1 years of follow-up
- description
- Sensitivity and specificity of positive utDNA for urothelial cancer, using histologically verified cancers detected within 1 year of the utDNA test as ground truth
Secondary outcomes (10)
- measure
- Specificity of positive utDNA for urothelial cancer at the time of testing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to provide informed consent * Diagnosis of Lynch syndrome * Age 50 - 75 years at study recruitment Exclusion Criteria: * Concurrent urothelial carcinoma
References
Publications (0)
Data not yet available