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ACTIVE NOT RECRUITING
NCT07447544
NA

Predictive Factors for CNS Metastases in Early Breast Cancer Using Liquid Biopsy (AKRA CŽS)

Sponsor: Institute of Oncology Ljubljana

View on ClinicalTrials.gov

Summary

Breast cancer is the most common cancer in women. Although most patients are diagnosed at an early stage and treated with curative intent, some later develop metastases to the central nervous system (CNS), which are associated with poor prognosis and high morbidity. Currently, there are no validated biomarkers that reliably predict which patients with early-stage breast cancer are at increased risk for CNS metastases. This study aims to identify molecular predictors of CNS metastases in early breast cancer. Gene expression profiles (mRNA) from archived primary tumor tissue will be analyzed using next-generation sequencing (NGS). In addition, serum concentrations of chemokines CX3CL1, CXCL13, and CXCL8 (IL-8), measured at the time of diagnosis using ELISA, will be evaluated for their association with subsequent CNS metastases. The results may improve risk stratification and support earlier identification of patients at increased risk for CNS spread.

Official title: Predictive Factors in Primary Tumor and Liquid Biopsy for the Spread of Early Breast Cancer to the Central Nervous System

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2025-07-07

Completion Date

2027-12

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Primary Tumor mRNA Expression Profiling (NGS)

Gene expression profiling of mRNA derived from archived primary breast tumor tissue using next-generation sequencing (NGS) to identify genes differentially expressed between patients who developed CNS metastases and matched controls.

DIAGNOSTIC_TEST

Serum Chemokine Quantification (ELISA)

Measurement of serum concentrations of chemokines CX3CL1, CXCL13, and CXCL8 (IL-8) collected at diagnosis using enzyme-linked immunosorbent assay (ELISA) to evaluate their association with subsequent CNS metastases.

Locations (1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia