Serum PTEN Levels and Organ-Specific microRNA Signatures as Predictors of Metastatic Patterns in Breast Cancer: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Serum PTEN Level
研究概览
简要总结
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.
详细描述
Breast cancer is a heterogeneous disease with varying biological behaviors and a strong tendency to metastasize to specific organs, including the bone, liver, lung, and brain. The development of distant metastases remains the primary cause of breast cancer-related mortality. Therefore, the identification of reliable, minimally invasive biomarkers that can predict metastatic spread is a critical unmet clinical need.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Metastatic Breast Cancer
Participants diagnosed with breast cancer and radiologically confirmed distant metastasis to bone, liver, lung, or brain.
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.
Healthy Controls
Age-matched healthy individuals without known malignancy or active systemic disease.
结局指标
主要结局
Serum PTEN Level
时间窗: At enrollment (single blood draw)
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.
Serum microRNA (miRNA) Expression Levels
时间窗: At enrollment
Expression levels of selected organ-specific microRNAs (bone, lung, liver, and brain associated miRNAs) measured by qRT-PCR in all study groups.
次要结局
- Correlation Between Biomarker Levels and Metastatic Organ Involvement(At enrollment)
- Comparison of Biomarker Levels Between Single-Organ and Multi-Organ Metastasis(At enrollment)
- Correlation Between Biomarkers and Clinical Variables(At enrollment)
研究者
Emine YILDIRIM
associate professor, MD
Atlas University