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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ 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

Locations
Other Locations
Italy
IRCCS National Cancer Institute Regina Elena
RECRUITING
Rome
Contact Information
Primary
Giuseppe Simone, Medical Doctor
giuseppe.simone@ifo.it
+39 0652665005
Time Frame
Start Date: 2024-08-06
Estimated Completion Date: 2026-02-06
Participants
Target number of participants: 100
Treatments
Patients suffering from bladder cancer
Patients with a proven diagnosis of muscle-infiltrating or non-muscle-infiltrating bladder cancer, having performance status (PS) 0-1.
Healthy persons.
Healthy persons with no previous or current medical history associated with bladder cancer or diagnostic suspicion associated with cancer, to be used as a relative reference.
Related Therapeutic Areas
Sponsors
Collaborators: Azienda Ospedaliera Santa Maria Degli Angeli, Istituto per lo Studio, la Prevenzione e la Rete Oncologica
Leads: Regina Elena Cancer Institute

This content was sourced from clinicaltrials.gov