Evaluating DNA Markers in Urothelial Tumors
Official title: Study for the Evaluation of Molecular Markers Extracted From PRedittivI DNA of Clinical Outcomes and Response to Systemic Therapy in Patients With UROthelial Tumor.
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06863844 · Data updated 2026-11-12
This study is testing if certain genetic markers in bladder cancer tumors can help predict how aggressive the cancer is and how well patients will respond to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | March 31, 2025 |
| Study ends | March 31, 2025 |
| Registry record updated | March 7, 2025 |
| Trial ID | NCT06863844 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years old diagnosed with locally advanced or metastatic urothelial neoplasia who have available tumor tissue for analysis.
✕Probably not a fit
Patients who are deceased or have not undergone the necessary genetic analysis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on the genetic analysis of tumor tissue from patients with urothelial cancer to identify molecular markers that may indicate the aggressiveness of the disease and its response to treatment. It involves both retrospective and prospective evaluations, utilizing next-generation sequencing to analyze DNA profiles. The study aims to correlate these molecular profiles with clinical outcomes and treatment sensitivity or resistance. Data will be collected from patient histories, clinical assessments, and various diagnostic tests.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with urothelial tumors based on their specific molecular profiles.
How similar studies have gone: Similar studies utilizing molecular profiling in cancer treatment have shown promise, indicating that this approach could yield valuable insights, although the specific methodology here may be novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria For the retrospective part: \- Patients diagnosed with locally advanced operated or metastatic urothelial cancer in follow-up or treatment Exclusion Criteria For the retrospective part: \- Deceased patients who have not already performed the NGS analysis from clinical practice. For the prospective part: Patients * aged \> 18 years * suffering from locally advanced or metastatic urothelial neoplasia * with the availability of tumor tissue obtained during surgery on a primary tumor or metastasis or during a diagnostic biopsy. Patients included in the study will also have to consciously express their willingness to participate in the study after signing the written informed consent.
Where it's running
-
IRCCS Azienda Ospedaliero Universitaria Bologna
Bologna, Italy Recruiting
Study contacts
- Principal investigator: Francesco Massari, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Francesco Massari, MD
- Email: francesco.massari@aosp.bo.it
- Phone: +390512142204
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.