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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute

About this trial

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 criteria

Qualifiers

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

Disqualifiers

presence of metastatic bladder cancer

lack of autonomy in following the procedures established by the study

previous or current clinical history associated with bladder cancer

diagnostic suspicion associated with tumor pathologies

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

100 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Regina Elena Cancer Institute

Lead sponsor

Azienda Ospedaliera Santa Maria Degli Angeli

Collaborator

Istituto per lo Studio, la Prevenzione e la Rete Oncologica

Collaborator