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Cancer Screening

Urine Tumor DNA Test for Lynch Syndrome

N/A
Recruiting
Led By Jussi Nikkola, MD, PhD
Research Sponsored by Tampere University Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 50 - 75 years at study recruitment
Diagnosis of Lynch syndrome
Must not have
Concurrent urothelial carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1, 2, 5 and 10 years of follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find new ways to detect cancer in people with Lynch syndrome, a genetic condition that increases the risk of certain cancers. Specifically, the trial will use urine samples to look for signs of

Who is the study for?
This trial is for individuals with Lynch Syndrome, a genetic condition that increases cancer risk. It's focused on detecting urothelial cancers early, which include bladder and upper urinary tract tumors. Participants should have this inherited syndrome but no current symptoms of urothelial cancer.
What is being tested?
The study is testing the effectiveness of a new urine tumor DNA test to screen for urothelial cancer in people with Lynch Syndrome. This will be compared to the standard urine cytology method to see if it can better detect cancer early.
What are the potential side effects?
Since this trial involves non-invasive screening methods using urine samples, there are minimal expected side effects. The main concerns may relate to the anxiety or stress from undergoing regular cancer screenings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 75 years old.
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I have been diagnosed with Lynch syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have urothelial carcinoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year of follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year of follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity and specificity of positive utDNA for urothelial cancer within one year of follow-up
Secondary study objectives
Overall survival
Sensitivity and specificity of positive utDNA for urothelial cancer within multiple years of follow-up
Size of urothelial tumors
+7 more
Other study objectives
Association of utDNA fraction with time to diagnosis of urothelial cancer
Cost of utDNA screening
Prevalence of somatic second hit in MMR genes
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Screening armExperimental Treatment2 Interventions
Invitation to participate in urothelial cancer screening and questionnaires

Find a Location

Who is running the clinical trial?

Tampere UniversityOTHER
164 Previous Clinical Trials
2,276,078 Total Patients Enrolled
Tampere University HospitalLead Sponsor
291 Previous Clinical Trials
387,128 Total Patients Enrolled
Jussi Nikkola, MD, PhDPrincipal InvestigatorTampere University Hospital
~33 spots leftby Apr 2025
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