Prognostic Biomarkers in Patients With Urothelial Carcinoma

NCT ID: NCT04872036

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-05-31
• Study Completion Date: 2017-06-30

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.

Conditions

Bladder Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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Other Identifiers

Biomarkers_Urothelial

Identifier Type: -

Identifier Source: org_study_id