Blood test for PTEN and organ-specific microRNAs to detect metastatic patterns in breast cancer
Official title: Serum PTEN Levels and Organ-Specific microRNA Signatures as Predictors of Metastatic Patterns in Breast Cancer: A Prospective Observational Study
Run by Atlas University · NCT07297134 · Data updated 2026-11-12
We will test whether blood levels of PTEN and organ-specific microRNAs can distinguish women with metastatic breast cancer from those with early-stage disease and healthy controls.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 160 (estimated) |
| Sponsor | Atlas University Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07297134 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are women aged 18 or older who can provide informed consent and either have histopathologically confirmed metastatic breast cancer, early-stage non-metastatic breast cancer, or are healthy controls without a history of malignancy.
✕Probably not a fit
Patients with other active primary malignancies, current immunosuppressive therapy, active infection or inflammatory conditions, severe hepatic/renal/hematologic dysfunction, or who are pregnant or breastfeeding are unlikely to benefit from the study's biomarker findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study measuring serum PTEN and organ-specific microRNA profiles in three groups: metastatic breast cancer (n=80), early-stage non-metastatic breast cancer (n=40), and healthy controls (n=40). Blood samples will be analyzed by qRT-PCR for miRNA profiling and by ELISA for PTEN quantification. The primary aim is to identify serum biomarkers that differentiate metastatic from non-metastatic disease, with secondary analyses correlating biomarker levels to specific metastatic sites (bone, lung, liver, brain). Findings may inform development of a noninvasive serum tool to predict metastatic patterns in breast cancer.
Why it matters
Potential benefit: If successful, this work could lead to a noninvasive blood test that helps predict where breast cancer may spread and guide surveillance and treatment decisions.
How similar studies have gone: Previous research has reported promising associations between circulating miRNA signatures, PTEN loss, and metastatic patterns, but these biomarkers remain preliminary and are not yet validated for routine clinical use.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Atlas University Faculty of Medicine
Istanbul, Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Emine Yildirim, MD
- Email: opdreyildirim@gmail.com
- Phone: +905056234825
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.