PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer

Summary

This prospective observational study aims to evaluate serum levels of PTEN, a tumor suppressor gene, and organ-specific microRNAs (miRNAs) associated with metastatic patterns in breast cancer. Serum samples will be analyzed using quantitative reverse transcription polymerase chain reaction (qRT-PCR)-based miRNA profiling and enzyme-linked immunosorbent assay (ELISA)-based PTEN quantification. Three groups will be included: patients with metastatic breast cancer (n=80), patients with non-metastatic early-stage breast cancer (n=40), and healthy controls (n=40). The primary objective is to identify serum biomarkers that differentiate metastatic from non-metastatic disease. Secondary analyses will evaluate correlations between biomarker levels and organ-specific metastatic involvement, including bone, lung, liver, and brain metastases. Findings from this study may support the development of a noninvasive serum-based tool for predicting metastatic patterns in breast cancer.

Eligibility

Inclusion Criteria:

* Female individuals aged ≥18 years
* Ability to provide written informed consent
* Group I (Metastatic BC): Histopathologically confirmed breast cancer and radiologically or clinically proven distant organ metastasis at the time of enrollment
* Group II (Non-Metastatic BC): Histopathologically confirmed breast cancer with no evidence of distant metastasis
* Group III (Healthy Controls): Women ≥18 years with no known breast disease and no personal history of malignancy

Exclusion Criteria:

* History of any other primary malignancy
* Known breast disease or breast cancer diagnosis in Group III
* Immunosuppressive therapy that may alter immune or biomarker profiles
* Active infection or inflammatory condition that may alter biomarker levels
* Inability or unwillingness to provide informed consent
* Severe hepatic, renal, or hematologic dysfunction
* Current pregnancy or lactation

Conditions5

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