NCT06878027Recruiting
Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
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
Source: ClinicalTrials.gov · Last updated 14 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 12 Feb 2025
- Start date
- 6 Aug 2024
- Primary completion date
- 6 Feb 2026
- Lead sponsor
- Regina Elena Cancer Institute
- Diseases
- Bladder cancer
- NCT number
- NCT06878027
What you commit to
- Study type: Observational
- Planned participants: 100
- From 6 Aug 2024 to the primary completion date, 6 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous or current clinical history associated with bladder cancer
- ongoing or previous systemic oncological treatments
Other illness
- presence of metastatic bladder cancer
- presence of inflammatory and/or autoimmune diseases related to particular conditions potentially modifying the methylation profile
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS National Cancer Institute "Regina Elena" Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.