Blood test for PTEN and organ-specific microRNAs to detect metastatic patterns in breast cancer
Serum PTEN Levels and Organ-Specific microRNA Signatures as Predictors of Metastatic Patterns in Breast Cancer: A Prospective Observational Study
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 |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Atlas University Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07297134 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul, Istanbul
- Atlas University Faculty of Medicine — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Emine Yildirim, MD
- Email: opdreyildirim@gmail.com
- Phone: +905056234825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.