Analyzing urine methylation patterns for early bladder cancer diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, observational pilot study investigates the diagnostic potential of methylation levels in urine samples for early detection of bladder cancer. It aims to validate commercially available tests and apply next-generation sequencing (NGS) to evaluate methylation profiles comprehensively. The study will assess the diagnostic performance of these methods in a real-world clinical setting and explore their economic impact as alternatives to conventional diagnostic practices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patient group

* age ≥ 18 years
* proven diagnosis of bladder cancer (infiltrating muscle or non-infiltrating muscle)
* performance status (PS) 0-1
* ability to follow the procedures established by the study
* written consent for participation in the study and data processing

group of healthy subjects

* age ≥ 18 years
* ability to follow the procedures established by the study
* written consent for participation in the study and data processing

Exclusion Criteria:

Patient group

* presence of metastatic bladder cancer
* lack of autonomy in following the procedures established by the study

group of healthy subjects

* previous or current clinical history associated with bladder cancer
* diagnostic suspicion associated with tumor pathologies
* ongoing or previous systemic oncological treatments
* presence of inflammatory and/or autoimmune diseases related to particular conditions potentially modifying the methylation profile
* existing pharmacological treatments (and/or any other type of treatment) that could alter the results of the analyzes conducted for the present study
* lack of autonomy in following the procedures established by the study

Where it's running

• IRCCS National Cancer Institute "Regina Elena"
  Rome, Italy Recruiting

Study contacts

• Study coordinator: Giuseppe Simone, Medical Doctor
• Email: giuseppe.simone@ifo.it
• Phone: +39 0652665005

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.