PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer

NCT07297134 | Recruiting

• 1 other identifier: MBC-PTEN-miRNA
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Metastatic Breast Cancer; miRNAs; PTEN

Keywords

Breast Cancer; Metastatic Breast Cancer; miRNAs; PTEN; Breast Cancer Biomarkers; Organ Specific Metastasis; miRNA Profiling

Outcome Measures

Primary Outcomes (2)

• Serum PTEN Level

  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

  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 Outcomes (3)

• Correlation Between Biomarker Levels and Metastatic Organ Involvement

  At enrollment

• Comparison of Biomarker Levels Between Single-Organ and Multi-Organ Metastasis

  At enrollment

• Correlation Between Biomarkers and Clinical Variables

  At enrollment

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Atlas University Faculty of Medicine

Istanbul, Istanbul, 34403, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples collected during routine venous blood draws for PTEN quantification and microRNA profiling

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Emine Yildirim, MD

CONTACT

+905056234825; opdreyildirim@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor, MD

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)