Prognostic Biomarkers in Patients With Urothelial Carcinoma

Investigation of Prognostic Biomarkers in Patients With Urothelial Carcinoma Treated With Platinum Regimens

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04872036

Enrollment

Registered

2021-05-04

Start date

2000-05-31

Completion date

2017-06-30

Last updated

2021-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Next Generation sequencing, TP53, ARID1A, ERCC2, BRACA2, DNA damage response, platinum sensitivity, muscle invasive, PD-L1, CD8, TILs, MMR

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assessment of mutational profile in patients with urothelial carcinoma	Up to 5 years

Secondary

Measure	Time frame
Association of mutational profile with PD-L1 expression	Up to 5 years
Association of the prognostic significance of mutations with respect to overall survival	Up to 5 years

Outcome results