The Evaluation of Molecular Markers From PRedittivI DNA of Clinical Outcomes in Patients With UROthelial Tumor

Condition(s) studied

Study 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

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy