Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urothelial cancer screening using urine tumor DNA test, Urothelial cancer screening using urine cytology (comparator).
- Who it may be relevant to
- Registry conditions: Urothelial Carcinoma, Lynch Syndrome. Basic parameters: 50 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada, Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Urothelial cancer screening using urine tumor DNA 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 - Diagnostic test Urothelial cancer screening using urine cytology (comparator)
Urine cytology sample
Primary outcome measures
- Sensitivity and specificity of positive utDNA for urothelial cancer within one year of follow-up [Time frame: At 1 years of follow-up]
Secondary outcome measures (10)
- Specificity of positive utDNA for urothelial cancer at the time of testing [Time frame: 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 [Time frame: At 2, 5, and 10 years of follow-up]
- Overall survival [Time frame: At 5 and 10 years of follow-up]
- Urothelial cancer specific survival [Time frame: At 3, 5 and 10 years of follow-up]
- Time to metastatic urothelial cancer [Time frame: At 5 and 10 years of follow-up]
- Time to diagnosis of muscle invasive or high grade urothelial cancer [Time frame: At 2, 5 and 10 years of follow-up]
- Time to diagnosis of urothelial cancer [Time frame: At 2, 5 and 10 years of follow-up]
- TNM pathological stage of urothelial cancers [Time frame: At 2, 5 and 10 years of follow-up]
- Size of urothelial tumors [Time frame: At 2, 5 and 10 years of follow-up]
- Urothelial cancer grade [Time frame: At 2, 5 and 10 years of follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Canada · 1 center
- Vancouver Prostate Centre — Vancouver
Finland · 1 center
- Tampere University Hospital and Tampere University — Tampere
Identifiers
NCT: NCT06218433 · R22125 · R22125