Analyzing urine methylation patterns for early bladder cancer diagnosis
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
This study is testing if checking for specific changes in urine can help doctors find bladder cancer earlier and more accurately.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06878027 on ClinicalTrials.gov |
What this trial studies
This multicenter, observational pilot study investigates the diagnostic potential of methylation levels in urine samples for early detection of bladder cancer. It aims to validate commercially available tests and apply next-generation sequencing (NGS) to evaluate methylation profiles comprehensively. The study will assess the diagnostic performance of these methods in a real-world clinical setting and explore their economic impact as alternatives to conventional diagnostic practices.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a proven diagnosis of bladder cancer and a performance status of 0-1.
Not a fit: Patients with metastatic bladder cancer or those unable to follow study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive and accurate method for early diagnosis of bladder cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using methylation patterns for cancer diagnosis, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rome
- IRCCS National Cancer Institute "Regina Elena" — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppe Simone, Medical Doctor
- Email: giuseppe.simone@ifo.it
- Phone: +39 0652665005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.