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
This trial accepts healthy volunteersQualifiers
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 population
Three groups were included in this study: women with metastatic breast cancer, women with early or locally advanced nonmetastatic breast cancer, and age-matched healthy female controls. Participants in the metastatic group have radiologically or clinically confirmed distant organ involvement. The nonmetastatic group includes patients with histopathologically confirmed breast cancer without any evidence of distant metastasis. Healthy controls consist of women without known breast disease, malignancy, or systemic illness. All participants are aged 18 years or older and able to provide informed consent. Recruitment will occur through oncology clinics, breast surgery units, and outpatient services.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 3 trial groupsGroup A: Metastatic Breast Cancer
Group B: Non-Metastatic Early-Stage Breast Cancer
Group C: Healthy Controls
Trial outcomes
Primary outcomes
1
Serum PTEN Level
Quantification of circulating PTEN protein levels in serum using enzyme-linked immunosorbent assay (ELISA) and comparison between metastatic breast cancer, non-metastatic breast cancer, and healthy control groups.
Time frame
At enrollment (single blood draw)2
Serum microRNA (miRNA) Expression Levels
Expression levels of selected organ-specific microRNAs (bone, lung, liver, and brain associated miRNAs) measured by qRT-PCR in all study groups.
Time frame
At enrollmentSecondary outcomes
1
Correlation Between Biomarker Levels and Metastatic Organ Involvement
Correlation of serum PTEN and miRNA expression levels with the presence of metastasis in specific organs (bone, liver, lung, brain).
Time frame
At enrollment2
Comparison of Biomarker Levels Between Single-Organ and Multi-Organ Metastasis
Comparison of serum PTEN and miRNA levels between patients with single-site metastasis and those with multi-site metastases.
Time frame
At enrollment3
Correlation Between Biomarkers and Clinical Variables
Exploratory analysis evaluating correlation between serum PTEN/miRNA levels and clinical features including hormone receptor status (ER/PR), HER2 status, age, tumor stage, and grade
Time frame
At enrollmentSponsors and contacts
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Source ClinicalTrials.gov