This study aims to prospectively observe whether certain alterations in some genes related to the DNA repair mechanism are related to better response to platinum-based chemotherapy used to treat metastatic bladder or urothelial cancers.
Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent.
Male or female patient ≥18 years of age.
Histological or cytological documentation of urothelial cancer.
Available tumor tissue for analysis
Previous treatment for metastatic or locally advanced disease.
Previous adjuvant therapy within 1 year from the diagnosis of metastatic disease.
Prior treatment with immunotherapy.
Previous or concurrent cancer that is distinct in primary site or histology from urothelial cancer within 3 years before enrollment EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ], and T1 [tumor invades lamina propria]), pT2 prostate cancer with PSA<0.01.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor