Breast CancerPTEN-miR-MBCNCT07297134
PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer
An observational study of Breast Cancer and Metastatic Breast Cancer, run by Atlas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, miRNAs
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atlas University Faculty of Medicine
Istanbul, Istanbul, 34403
EMİNE YILDIRIM, +905056234825, opdreyildirim@gmail.com
Hafize Uzun, PhD, 90 535 542 11 47, hafize.uzun@atlas.edu.tr
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Cancer, Metastatic Breast Cancer, miRNAs, PTEN
- Keywords
- Breast Cancer, Metastatic Breast Cancer, miRNAs, PTEN, Breast Cancer Biomarkers, Organ Specific Metastasis, miRNA Profiling
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At enrollment
Secondary outcomes (3)
Correlation Between Biomarker Levels and Metastatic Organ Involvement
Correlation of serum PTEN and miRNA expression levels with the presence of metastasis in specific organs (bone, liver, lung, brain).
Measured: At enrollment
Comparison of Biomarker Levels Between Single-Organ and Multi-Organ Metastasis
Comparison of serum PTEN and miRNA levels between patients with single-site metastasis and those with multi-site metastases.
Measured: At enrollment
Correlation Between Biomarkers and Clinical Variables
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
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine YILDIRIM, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297134
- Sponsor's protocol ID
- MBC-PTEN-miRNA
- Acronym
- PTEN-miR-MBC
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum PTEN Levels and Organ-Specific microRNA Signatures as Predictors of Metastatic Patterns in Breast Cancer: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07297134
- Acronym / sponsor ID
- PTEN-miR-MBC / MBC-PTEN-miRNA
- Conditions
- Breast Cancer, Metastatic Breast Cancer, miRNAs, PTEN
- Keywords
- Breast Cancer, Metastatic Breast Cancer, miRNAs, PTEN, Breast Cancer Biomarkers, Organ Specific Metastasis, miRNA Profiling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Correlation Between Biomarker Levels and Metastatic Organ Involvement
Time frame: At enrollment
Comparison of Biomarker Levels Between Single-Organ and Multi-Organ Metastasis
Time frame: At enrollment
Correlation Between Biomarkers and Clinical Variables
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Metastatic Breast Cancer, run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Yildirim, MD (+905056234825, opdreyildirim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum PTEN Level (time frame: At enrollment (single blood draw)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.