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Cancer Screening

Screening arm for Bladder Cancer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1, 2, 5 and 10 years of follow-up

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1, 2, 5 and 10 years of follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1, 2, 5 and 10 years of follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1, 2, 5 and 10 years of follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity and specificity of positive utDNA for urothelial cancer within one year of follow-up

Secondary outcome measures

Overall survival

Sensitivity and specificity of positive utDNA for urothelial cancer within multiple years of follow-up

Size of urothelial tumors

+7 more

Other outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Screening armExperimental Treatment2 Interventions

Invitation to participate in urothelial cancer screening and questionnaires

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tampere UniversityOTHER

151 Previous Clinical Trials

2,255,695 Total Patients Enrolled

Tampere University HospitalLead Sponsor

280 Previous Clinical Trials

380,211 Total Patients Enrolled

Jussi Nikkola, MD, PhDPrincipal InvestigatorTampere University Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical trial currently accepting new participants?

"Indeed, clinicaltrials.gov indicates that this trial is actively seeking participants. The original posting date was April 10th, 2023, and the most recent update occurred on January 22nd, 2024."

Answered by AI

Is the age criterion for participating in this medical study inclusive of individuals aged 60 years and above?

"Patients between the ages of 50 and 75 are eligible to participate in this trial. However, it is worth noting that there are currently 374 trials specifically targeting individuals under the age of 18 and an additional 1122 trials focusing on those over the age of 65."

Answered by AI

What is the current number of individuals being admitted into this research investigation?

"Indeed, the data available on clinicaltrials.gov indicates that this clinical trial is actively seeking eligible participants. The initial posting of the trial was made on April 10th, 2023, and it has been periodically updated since then, with the most recent update occurring on January 22nd, 2024. To complete the study successfully, a total of 200 individuals will be enrolled across two designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218433.