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Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool

Recruitingn/aAges 18 Years - anyAllRegina Elena Cancer Institute
NCT06878027 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Multicenter, observational, prospective, biological pilot study on liquid biopsy, aimed at investigating methylation profiles in relation to the early diagnosis of bladder cancer, to validate the potential of commercially available tests (e.g. BladderCARE, Bladder EpiCheck), to apply and validate tests based on targeted multi-marker or genome wide analyzes via NGS and to identify methylation profiles as a tool to infer clinical outcome.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
IRCCS National Cancer Institute "Regina Elena"
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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