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

Summary

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.

Eligibility

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

Conditions2

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