Actively Recruiting
Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
Led by Regina Elena Cancer Institute · Updated on 2025-03-14
100
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
R
Regina Elena Cancer Institute
Lead Sponsor
A
Azienda Ospedaliera Santa Maria Degli Angeli
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Proven diagnosis of bladder cancer (infiltrating muscle or non-infiltrating muscle)
- Performance status 0 or 1
- Ability to follow study procedures
- Written consent for participation and data processing
- Age 18 years or older (healthy subjects)
- Ability to follow study procedures (healthy subjects)
- Written consent for participation and data processing (healthy subjects)
You will not qualify if you...
- Presence of metastatic bladder cancer (patient group)
- Lack of autonomy in following study procedures (patient group)
- Previous or current history of bladder cancer (healthy subjects)
- Suspicion of tumor pathologies (healthy subjects)
- Ongoing or previous systemic oncological treatments (healthy subjects)
- Presence of inflammatory or autoimmune diseases that may affect methylation profiles (healthy subjects)
- Use of pharmacological or other treatments that could alter study analysis results (healthy subjects)
- Lack of autonomy in following study procedures (healthy subjects)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS National Cancer Institute "Regina Elena"
Rome, Italy, 00144
Actively Recruiting
Research Team
G
Giuseppe Simone, Medical Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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