Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool

Last updated: March 10, 2025
Sponsor: Regina Elena Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Urothelial Cancer

Urothelial Carcinoma

Treatment

N/A

Clinical Study ID

NCT06878027
RS194/IRE/24
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

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 conditionspotentially modifying the methylation profile

  • existing pharmacological treatments (and/or any other type of treatment) that couldalter the results of the analyzes conducted for the present study

  • lack of autonomy in following the procedures established by the study

Study Design

Total Participants: 100
Study Start date:
August 06, 2024
Estimated Completion Date:
February 06, 2026

Study 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.

Connect with a study center

  • IRCCS National Cancer Institute "Regina Elena"

    Rome, 00144
    Italy

    Active - Recruiting

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