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PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer

Study acronym: PTEN-miR-MBC
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 20, 2025 to Dec 1, 2025
    • Site details revised
    v3
  2. Secondary endpoints revised (3)v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07297134
Lead Sponsor Atlas University
Conditions
(from sponsor)		 Breast Cancer, Metastatic Breast Cancer, miRNAs, PTEN
Related terms Breast Neoplasms
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov