NCT07297134 PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer
| NCT ID | NCT07297134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Atlas University |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2025-12-01 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07297134 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07297134 currently recruiting?
Yes, NCT07297134 is actively recruiting participants. Contact the research team at opdreyildirim@gmail.com for enrollment information.
Where is the NCT07297134 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07297134 clinical trial?
NCT07297134 is sponsored by Atlas University. The trial plans to enroll 160 participants.
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