PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer (PTEN-miR-MBC)

January 26, 2026 updated by: Emine YILDIRIM, Atlas University

Serum PTEN Levels and Organ-Specific microRNA Signatures as Predictors of Metastatic Patterns in Breast Cancer: A Prospective Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Breast cancer is a heterogeneous disease with varying biological behaviors and a strong tendency to metastasize to specific organs, including the bone, liver, lung, and brain. The development of distant metastases remains the primary cause of breast cancer-related mortality. Therefore, the identification of reliable, minimally invasive biomarkers that can predict metastatic spread is a critical unmet clinical need.

MicroRNAs (miRNAs) are small, noncoding RNA molecules that regulate gene expression and have emerged as promising biomarkers due to their stability in the circulation and their association with cancer progression. Specific miRNA expression patterns have been linked to organotropism in breast cancer, including signatures associated with bone, lung, liver, and brain metastases. Additionally, PTEN is a key tumor suppressor gene involved in cell cycle regulation, apoptosis, and PI3K/AKT pathway signaling. Loss of PTEN function is frequently observed in aggressive and metastatic breast cancers, and reduced circulating PTEN levels may correlate with tumor burden and metastatic dissemination.

This prospective observational clinical study aims to evaluate serum PTEN levels and organ-specific miRNA profiles in three participant groups:

Metastatic breast cancer patients (n=80) diagnosed with distant organ involvement.

Early-stage non-metastatic breast cancer patients (n=40) with no radiological or clinical evidence of metastasis.

Healthy control participants (n=40) without known malignancy.

Serum samples will undergo laboratory analysis using two validated molecular techniques:

Quantitative reverse transcription polymerase chain reaction (qRT-PCR) for profiling selected miRNAs associated with organ-specific metastatic patterns.

Enzyme-linked immunosorbent assay (ELISA) for quantification of circulating PTEN protein levels.

The primary objective of the study is to compare serum PTEN and miRNA expression levels between metastatic and non-metastatic breast cancer groups, as well as healthy controls. Secondary objectives include assessing associations between these biomarkers and (a) the number of metastatic sites, (b) specific organ involvement (bone, lung, liver, brain), and (c) selected clinical characteristics, including hormone receptor status, HER2 expression, patient age, and stage at diagnosis.

The overarching goal is to characterize a panel of circulating biomarkers that may contribute to early detection of metastatic potential and organ-specific metastatic patterns in breast cancer. Identifying such signatures may facilitate noninvasive risk stratification, support personalized treatment planning, and form the basis for future translational research aimed at developing clinically applicable diagnostic assay

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Three groups were included in this study: women with metastatic breast cancer, women with early or locally advanced nonmetastatic breast cancer, and age-matched healthy female controls.

Participants in the metastatic group have radiologically or clinically confirmed distant organ involvement. The nonmetastatic group includes patients with histopathologically confirmed breast cancer without any evidence of distant metastasis. Healthy controls consist of women without known breast disease, malignancy, or systemic illness. All participants are aged 18 years or older and able to provide informed consent. Recruitment will occur through oncology clinics, breast surgery units, and outpatient services.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum PTEN Level
Time Frame: At enrollment (single blood draw)
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.
At enrollment (single blood draw)
Serum microRNA (miRNA) Expression Levels
Time Frame: At enrollment
Expression levels of selected organ-specific microRNAs (bone, lung, liver, and brain associated miRNAs) measured by qRT-PCR in all study groups.
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Biomarker Levels Between Single-Organ and Multi-Organ Metastasis
Time Frame: At enrollment
Comparison of serum PTEN and miRNA levels between patients with single-site metastasis and those with multi-site metastases.
At enrollment
Correlation Between Biomarker Levels and Metastatic Organ Involvement
Time Frame: At enrollment
Correlation of serum PTEN and miRNA expression levels with the presence of metastasis in specific organs (bone, liver, lung, brain).
At enrollment
Correlation Between Biomarkers and Clinical Variables
Time Frame: At enrollment
Exploratory analysis evaluating correlation between serum PTEN/miRNA levels and clinical features including hormone receptor status (ER/PR), HER2 status, age, tumor stage, and grade
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBC-PTEN-miRNA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to privacy and data protection regulations. Only de-identified, aggregate results may be shared with researchers upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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