Clinical trial · Observational
The Evaluation of Molecular Markers From PRedittivI DNA of Clinical Outcomes in Patients With UROthelial Tumor
Study for the Evaluation of Molecular Markers Extracted From PRedittivI DNA of Clinical Outcomes and Response to Systemic Therapy in Patients With UROthelial Tumor.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The genetic characterization of urothelial tumor disease has brought to light important information about the biology of the disease. The evaluation of molecular DNA markers on tumor tissue could be an approach able to provide important information on the possible aggressiveness of the disease and the sensitivity/resistance profile to drugs commonly adopted in the advanced stage. The main objective of this study is to identify specific molecular profiles from DNA capable of predicting the clinical course of the disease and the possible sensitivity/resistance of the disease to systemic treatments
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Neoplasm | Urothelial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- evaluation of the prognostic and predictive role of response to systemic therapy of specific molecular markers extracted from tumor DNA.
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
- description
- The study involves the analysis by massive sequencing (Next Generation Sequencing) of molecular profiles of tumor DNA extracted from tumor tissue obtained during surgery (on primary and/or metastases) or diagnostic biopsy performed as part of the normal clinical care pathway. These data will be integrated with information relating to anamnestic data and clinical, laboratory and instrumental parameters of patients with urothelial neoplasia
Secondary outcomes (1)
- measure
- molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
- description
- Search for molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available