Urothelial Neoplasm
Conditions
Keywords
biomarker
Brief summary
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
Detailed description
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of the prognostic and predictive role of response to systemic therapy of specific molecular markers extracted from tumor DNA. | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy | 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 | Search for molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy |
Countries
Italy
Contacts
Primary ContactFrancesco Massari, MD
Outcome results
None listed