Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)

NCT ID: NCT06218433

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2034-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urothelial Carcinoma Lynch Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening arm

Invitation to participate in urothelial cancer screening and questionnaires

Group Type EXPERIMENTAL

Urothelial cancer screening using urine tumor DNA test

Intervention Type DIAGNOSTIC_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)

Intervention Type DIAGNOSTIC_TEST

Urine cytology sample

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Urothelial cancer screening using urine cytology (comparator)

Urine cytology sample

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jussi Nikkola, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Vancouver Prostate Centre

Vancouver, , Canada

Site Status RECRUITING

Tampere University Hospital and Tampere University

Tampere, , Finland

Site Status RECRUITING

Countries

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Canada Finland

Central Contacts

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Jussi Nikkola, MD, PhD

Role: CONTACT

03311611 ext. +358

Facility Contacts

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Peter Black

Role: primary

Jussi Nikkola

Role: primary

Other Identifiers

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R22125

Identifier Type: OTHER

Identifier Source: secondary_id

R22125

Identifier Type: -

Identifier Source: org_study_id

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