PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer
NCT ID: NCT07297134
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
160 participants
OBSERVATIONAL
2025-12-20
2026-12-31
Brief Summary
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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.
Detailed Description
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MicroRNAs (miRNAs) are small, noncoding RNA molecules that regulate gene expression and have emerged as promising biomarkers due to their stability in the circulation and their association with cancer progression. Specific miRNA expression patterns have been linked to organotropism in breast cancer, including signatures associated with bone, lung, liver, and brain metastases. Additionally, PTEN is a key tumor suppressor gene involved in cell cycle regulation, apoptosis, and PI3K/AKT pathway signaling. Loss of PTEN function is frequently observed in aggressive and metastatic breast cancers, and reduced circulating PTEN levels may correlate with tumor burden and metastatic dissemination.
This prospective observational clinical study aims to evaluate serum PTEN levels and organ-specific miRNA profiles in three participant groups:
Metastatic breast cancer patients (n=80) diagnosed with distant organ involvement.
Early-stage non-metastatic breast cancer patients (n=40) with no radiological or clinical evidence of metastasis.
Healthy control participants (n=40) without known malignancy.
Serum samples will undergo laboratory analysis using two validated molecular techniques:
Quantitative reverse transcription polymerase chain reaction (qRT-PCR) for profiling selected miRNAs associated with organ-specific metastatic patterns.
Enzyme-linked immunosorbent assay (ELISA) for quantification of circulating PTEN protein levels.
The primary objective of the study is to compare serum PTEN and miRNA expression levels between metastatic and non-metastatic breast cancer groups, as well as healthy controls. Secondary objectives include assessing associations between these biomarkers and (a) the number of metastatic sites, (b) specific organ involvement (bone, lung, liver, brain), and (c) selected clinical characteristics, including hormone receptor status, HER2 expression, patient age, and stage at diagnosis.
The overarching goal is to characterize a panel of circulating biomarkers that may contribute to early detection of metastatic potential and organ-specific metastatic patterns in breast cancer. Identifying such signatures may facilitate noninvasive risk stratification, support personalized treatment planning, and form the basis for future translational research aimed at developing clinically applicable diagnostic assay
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Metastatic Breast Cancer
Participants diagnosed with breast cancer and radiologically confirmed distant metastasis to bone, liver, lung, or brain.
No interventions assigned to this group
Non-Metastatic Early-Stage Breast Cancer
Participants diagnosed with early-stage and local advenced (Stage I-III) breast cancer with no clinical or radiological evidence of distant metastasis.
No interventions assigned to this group
Healthy Controls
Age-matched healthy individuals without known malignancy or active systemic disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Atlas University
OTHER
Responsible Party
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Emine YILDIRIM
associate professor, MD
Locations
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Atlas University Faculty of Medicine
Istanbul, Istanbul, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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EMİNE YILDIRIM
Role: primary
Hafize Uzun, PhD
Role: backup
Other Identifiers
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MBC-PTEN-miRNA
Identifier Type: -
Identifier Source: org_study_id