PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer

Sponsor
Atlas University
Study ID
NCT07297134
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Dec 22, 2025
Start date
Dec 1, 2025
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)

Arms

  • Arm: Metastatic Breast Cancer
    Participants diagnosed with breast cancer and radiologically confirmed distant metastasis to bone, liver, lung, or brain.
  • Arm: 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.
  • Arm: Healthy Controls
    Age-matched healthy individuals without known malignancy or active systemic disease.

Primary Outcome Measure

Serum PTEN Level [ Time Frame: At enrollment (single blood draw) ]

Central Contacts

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