PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAtlas University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
160 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov