Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
NCT07297134

PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer

Led by Atlas University · Updated on 2026-01-27

160

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female individuals aged 6518 years
  • Ability to provide written informed consent
  • Histopathologically confirmed breast cancer with distant organ metastasis for metastatic group
  • Histopathologically confirmed breast cancer with no evidence of distant metastasis for non-metastatic group
  • Women aged 6518 years with no known breast disease and no personal history of malignancy for healthy controls
Not Eligible

You will not qualify if you...

  • History of any other primary malignancy
  • Known breast disease or breast cancer diagnosis in healthy control group
  • Receiving immunosuppressive therapy that may affect immune or biomarker profiles
  • Active infection or inflammatory condition that may affect biomarker levels
  • Inability or unwillingness to provide informed consent
  • Severe liver, kidney, or blood disorders
  • Current pregnancy or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

Atlas University Faculty of Medicine

Istanbul, Istanbul, Turkey (Türkiye), 34403

Actively Recruiting

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Research Team

E

Emine Yildirim, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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