NCT07297134Recruiting
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 · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 160 (estimated)
- First submitted
- 9 Dec 2025
- Start date
- 1 Dec 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- Atlas University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07297134
What you commit to
- Study type: Observational
- Planned participants: 160
- From 1 Dec 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immunosuppressive therapy that may alter immune or biomarker profiles
Other illness
- History of any other primary malignancy
- Known breast disease or breast cancer diagnosis in Group III
- Active infection or inflammatory condition that may alter biomarker levels
Other
- Inability or unwillingness to provide informed consent
- Severe hepatic, renal, or hematologic dysfunction
- Current pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atlas University Faculty of Medicine Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.