Clinical trial · Interventional
Predictive Factors for CNS Metastases in Early Breast Cancer Using Liquid Biopsy (AKRA CŽS)
Predictive Factors in Primary Tumor and Liquid Biopsy for the Spread of Early Breast Cancer to the Central Nervous System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Central Nervous System Metastases | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primary Tumor mRNA Expression Profiling (NGS) | Diagnostic Test | — | UNRESOLVED |
| Serum Chemokine Quantification (ELISA) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CNS Metastases Group
- description
- Female patients with early-stage breast cancer who developed central nervous system (CNS) metastases during follow-up. Participants undergo molecular biomarker assessment consisting of primary tumor mRNA gene expression profiling using next-generation sequencing (NGS) and measurement of baseline serum chemokine concentrations (CX3CL1, CXCL13, CXCL8 \[IL-8\]) using ELISA.
- interventionNames
- Diagnostic Test: Primary Tumor mRNA Expression Profiling (NGS)
- Diagnostic Test: Serum Chemokine Quantification (ELISA)
- type
- ACTIVE_COMPARATOR
- label
- Control Group (No CNS Metastases)
- description
- Matched female patients with early-stage breast cancer who did not develop CNS metastases during follow-up. Participants undergo molecular biomarker assessment consisting of primary tumor mRNA gene expression profiling using next-generation sequencing (NGS) and measurement of baseline serum chemokine concentrations (CX3CL1, CXCL13, CXCL8 \[IL-8\]) using ELISA.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18 years or older. * Diagnosis of early-stage breast cancer. * Availability of archived primary tumor tissue suitable for mRNA analysis. * Availability of serum sample suitable for chemokine analysis. * Patients included in the AKRA cohort with documented follow-up data. * Patients with confirmed CNS metastases during follow-up (CNS metastases group) or matched controls without CNS metastases (control group). Exclusion Criteria: * Male breast cancer patients. * Lack of sufficient primary tumor tissue for mRNA analysis. * Lack of available serum sample for chemokine analysis. * Incomplete clinical follow-up data preventing classification of CNS metastasis status.
References
Publications (0)
Data not yet available