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Taking people in ItalyNo phase

Urine tests for DNA changes to find bladder cancer early

Studies urine DNA patterns to detect and track bladder cancer in adults.

Key facts

Who runs it
Regina Elena Cancer Institute
Where
Rome, ItalySee the site
Trial code
Registry title
Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
Status
Recruiting
People taking part
100 people, planned
Started
6 Aug 2024
Planned end
6 Feb 2026
Type of study
Observational, 2 groups
Record updated
14 March 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with bladder cancer that has not spread to other organs, and also healthy adult volunteers. It studies urine tests for early diagnosis.

Age
18 years or older
Sex
All sexes can join
Disease stage
Bladder cancer, either growing into the muscle or not. Metastatic (spread) bladder cancer cannot join.
Earlier treatment
Healthy volunteers must not have had or be having systemic cancer treatment.

Main reasons for not taking part

  • Metastatic bladder cancer (patient group)
  • Cannot follow the study procedures on their own
  • Healthy group: past or current bladder cancer, or suspected tumour disease
  • Healthy group: inflammatory or autoimmune disease that might change the methylation profile
  • Healthy group: other treatments that could change the test results

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • previous or current clinical history associated with bladder cancer
  • ongoing or previous systemic oncological treatments
  • presence of metastatic bladder cancer
  • presence of inflammatory and/or autoimmune diseases related to particular conditions potentially modifying the methylation profile
  • Patient group
  • lack of autonomy in following the procedures established by the study; group of healthy subjects
  • diagnostic suspicion associated with tumor pathologies
  • 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

Where in Italy

  • IRCCS National Cancer Institute "Regina Elena"Rome, ItalyContact: Giuseppe Simone, Medical DoctorTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • 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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Urine tests for DNA changes to find bladder cancer earlyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
14 March 2025