Recruiting

PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer

ClinicalTrials.gov IDNCT07297134

PhaseNot Applicable

Enrollment160

SponsorAtlas University

Age18 Years and older

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, Metastatic Breast Cancer, miRNAs, PTEN

About this study

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.

Primary outcomes

Serum PTEN Level (At enrollment (single blood draw))
Serum microRNA (miRNA) Expression Levels (At enrollment)

Eligibility information

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

Study locations

Atlas University Faculty of Medicine, Istanbul, Istanbul 34403 Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-03.