Clinical trial NCT06878027: Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Keywords: methylation levels in urine samples
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Santa Maria Degli Angeli
name: Istituto per lo Studio, la Prevenzione e la Rete Oncologica
First posted: 2025-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by non-muscle infiltrating bladder cancer

Brief 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.

Detailed description: The study has the primary objective to investigate the diagnostic capacity of methylation levels in urine samples, furthermore it has the secondary objective of applying an NGS test on the urine sample capable of evaluating the highest methylation levels comprehensive, with better analytical performance than the currently available standard on the market, leveraging targeted sequencing of multiple genes or global analysis of the whole methylome.

To describe the diagnostic performance of the methods in a real-world clinical environment and identify the characteristic methylation profiles capable of stratifying patients with different prognoses, and finally to explore the potential economic impact of applying such tests as tools alternatives to conventional practices.

Eligibility criteria: 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

Primary outcomes:
measure: Methylation state
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS National Cancer Institute "Regina Elena"
Study officials:
References: