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Biomarkers in Patients With Metastatic Breast Cancer

NCT05871788 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1600

Last updated 2023-05-23

No results posted yet for this study

Summary

In order to allow Tunisian patients with breast cancer to access immunotherapies, and innovative treatments to extend life expectancy of patients with breast cancer with a poor prognosis, it is important to study the epidemiological profile of Tunisian cancers breast, in terms of PD-L1 expression, tumor mutational burden (TMB), microsatellite instability status (MSI) and rate of TILs, in metastatic and locally advanced cases, in Tunis, over a one-year follow-up period.

It is also important to study other inflammatory and tumor biomarkers which would have a prognostic or even therapeutic value:

* serum dosage of LDH (lactate dehydrogenase)
* IL-6 (interleukin 6)
* CRP (C-reactive protein)
* absolute count of lymphocytes (CLA) and eosinophils
* quantification of circulating tumor DNA before treatment and under treatment. The primary objective id to identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma before and during the systemic treatment.

Conditions

  • Identify the Number of Eligible Patients for Immunotherapy According to the Epidemiological and Biological Profile in Tunisia

Interventions

DIAGNOSTIC_TEST

identify biomarkers

Identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma

Sponsors & Collaborators

  • Tunisian Association for Immuno-oncology Research

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2027-06-30
Completion
2027-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05871788 on ClinicalTrials.gov