Prognostic Biomarkers in Patients With Urothelial Carcinoma

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872036
• Other study ID #: Biomarkers_Urothelial
• Status: Completed
• Start date: May 2000
• Est. completion date: June 2017

Study information

• Verified date: April 2021
• Source: Hellenic Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Cooperative Oncology Group

References & Publications (66)

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* Note: There are 66 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of mutational profile in patients with urothelial carcinoma		Up to 5 years
Secondary	Association of mutational profile with PD-L1 expression		Up to 5 years
Secondary	Association of the prognostic significance of mutations with respect to overall survival		Up to 5 years