Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
NCT ID: NCT06878027
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-08-06
2026-02-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Azienda Ospedaliera Santa Maria Degli Angeli
OTHER
Istituto per lo Studio, la Prevenzione e la Rete Oncologica
OTHER
Regina Elena Cancer Institute
OTHER
Responsible Party
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Locations
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IRCCS National Cancer Institute "Regina Elena"
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RS194/IRE/24
Identifier Type: -
Identifier Source: org_study_id
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