Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
Key facts
- Where
- Rome, ItalySee the site
Where in Italy
- IRCCS National Cancer Institute "Regina Elena"Rome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regina Elena Cancer Institute
- Trial code
- NCT06878027
- Record updated
- 14 March 2025
- Original description
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.Read full original descriptionShow less
Analysis of Urinary Methylation Patterns Via Liquid Biopsy as a Tool for Early Diagnosis, Non-invasive Monitoring and Prediction of Recurrence Risk in Bladder Cancer
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.
Inclusion: 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: previous or current clinical history associated with bladder cancer; ongoing or previous systemic oncological treatments; presence of metastatic bladder cancer; presence of inflammatory and/or autoimmune diseases related to particular conditions potentially modifying the methylation profile; Patient group; lack of autonomy in following the procedures established by the study; group of healthy subjects; diagnostic suspicion associated with tumor pathologies; 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.