Clinical trial · Observational
PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer
Serum PTEN Levels and Organ-Specific microRNA Signatures as Predictors of Metastatic Patterns in Breast Cancer: A Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| miRNAs | — | UNRESOLVED | — |
| PTEN | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Metastatic Breast Cancer
- description
- Participants diagnosed with breast cancer and radiologically confirmed distant metastasis to bone, liver, lung, or brain.
- label
- Non-Metastatic Early-Stage Breast Cancer
- description
- Participants diagnosed with early-stage and local advenced (Stage I-III) breast cancer with no clinical or radiological evidence of distant metastasis.
- label
- Healthy Controls
- description
- Age-matched healthy individuals without known malignancy or active systemic disease.
Primary outcomes (2)
- measure
- Serum PTEN Level
- timeFrame
- At enrollment (single blood draw)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available