Prognostic Biomarkers in Patients With Urothelial Carcinoma

N/ACompletedNCT04872036

Hellenic Cooperative Oncology Group66 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bladder Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Urothelial carcinoma located in bladder * Patients treated with platinum regimens at the neoadjuvant . adjuvant setting * Written informed consent for the use of biological material Exclusion Criteria: \-

Outcomes

Primary Outcomes

Assessment of mutational profile in patients with urothelial carcinoma

Time frame: Up to 5 years

Secondary Outcomes

Association of mutational profile with PD-L1 expression

Time frame: Up to 5 years

Association of the prognostic significance of mutations with respect to overall survival

Time frame: Up to 5 years

Data from ClinicalTrials.gov

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