An observational study in Urothelial Neoplasm, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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
retrospective and prospective evaluation concerning the identification of molecular profiles on DNA obtained from tumor tissue previously obtained from patients with urothelial cancer and analyzed with massive sequencing method (Next Generation Sequencing).
Analysis of data obtained from anamnestic data, clinical data, blood chemistry tests, histopathological examinations and instrumental imaging.
IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with urothelial cancer
Exclusion Criteria For the retrospective part:
For the prospective part:
Patients
Patients included in the study will also have to consciously express their willingness to participate in the study after signing the written informed consent.
evaluation of the prognostic and predictive role of response to systemic therapy of specific molecular markers extracted from tumor DNA.
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
Time frame: 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
molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy
Search for molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy
Time frame: 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
Plan to share: No
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IRCCS Azienda Ospedaliero-Universitaria di Bologna