Prognostic Biomarkers in Patients With Urothelial Carcinoma
- Conditions
- Bladder Cancer
- Registration Number
- NCT04872036
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Bladder cancer (BC) is a heterogeneous malignancy with dismal outcome.Despite treatment, the 5-year overall survival rates for MIBC are \<50%, with many patients unresponsive or inapt, necessitating biomarkers to select those most likely to respond or fit for treatment
- Detailed Description
In this study was assessed the associations among most frequently mutated genes and with clinicopathological features, as well as the prognostic significance of the presence of mutations in the top mutated and DNA Damage response (DDR) mutated genes in terms of Overall Survival (OS). Moreover, overall tumor-infiltrating lymphocytes (TILs) density was measured, analyzed immunohistochemically the expression of PD-L1, the four MMR proteins (MLH1, MSH2, MSH6 and PMS2) and tumor or stromal CD8+ cytotoxic T lymphocyte infiltrates and assessed their association with each other, top mutated genes and available clinicopathological parameters together with their role in prognosis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- Urothelial carcinoma located in bladder
- Patients treated with platinum regimens at the neoadjuvant . adjuvant setting
- Written informed consent for the use of biological material
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of mutational profile in patients with urothelial carcinoma Up to 5 years
- Secondary Outcome Measures
Name Time Method Association of the prognostic significance of mutations with respect to overall survival Up to 5 years Association of mutational profile with PD-L1 expression Up to 5 years