Breast CancerNCT07833566
Biopsy-site-marker in Breast Cancer
An observational study of Breast Cancer, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to explore pro-metastatic changes in breast cancer (BC) associated with the stiffness of biopsy site markers. This study aims to determine whether the stiffness of a biopsy site marker promotes inflammatory changes in breast cancer and to evaluate whether there is a relationship between… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Biopsy-Site Marker Placement.
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2026to Jul 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received biopsy-site marker during diagnosis outside the OUBI OKC campus and were referred to OUBI for surgery as the first definitive treatment.
Who may be able to join
- Written informed consent (ICF) signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses.
- Female patients at > 18 years of age at the time of signature of the ICF.
- Pathologically verified invasive breast cancer cases referred to OU for surgery.
Who cannot join
- Patients who had a biopsy at OUBI OKC.
- Patient who will undergo neoadjuvant therapy
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active viral infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
- Currently pregnant or breastfeeding
- Patients not eligible for surgery
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Takemi Tanaka, PhD contact
United States1 site, 1 recruiting
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
Takemi Tanaka, PhD, Takemi-Tanaka@ou.edu
About this study
Official title: Inflammation and Biopsy-site-marker in Breast Cancer (MOSAIC)
The purpose of this study is to explore pro-metastatic changes in breast cancer (BC) associated with the stiffness of biopsy site markers. This study aims to determine whether the stiffness of a biopsy site marker promotes inflammatory changes in breast cancer and to evaluate whether there is a relationship between biopsy site marker stiffness and inflammation.
Read the detailed description
This prospective study aims to evaluate whether anti-inflammatory and pro-metastatic changes at the post-biopsy site are associated with the type of biopsy-site marker used, with particular focus on marker stiffness. Tissue samples will be collected from breast cancer patients who received a biopsy-site marker at the time of diagnosis.
- Conditions
- Breast Cancer
- Being tested
- Biopsy-Site Marker Placement.
- Keywords
- Biopsy Site Marker, Lumpectomy, Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy-Site Marker Placement.Device
Tissue samples will be collected from Breast Cancer patients, stages I-III, who underwent lumpectomy (mastectomy) after biopsy site marker placement during image-guided biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients | 140 patients will be assigned to this group. Receives: Device: Biopsy-Site Marker Placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Evaluable Tissue Samples.
To process 100 surgically resected breast tumors that had needle biopsy and biopsy site marker placement outside OKC downtown campus.
Measured: 1 year
Differences in Stiffness of Tissue Samples Collected During Surgical Biopsy.
We will conduct a spatiotemporal analysis of surgically resected tissues to evaluate whether the stiffness of the chemical materials is associated with an anti-inflammatory microenvironment and a higher prevalence of epithelial-mesenchymal transition (EMT) in cancer cells. To better characterize these differences, we will assess phenotypic changes using multiplex immunofluorescence on resected surgical specimens with the biopsy site marker in place, enabling precise spatial localization and comparison of tissue responses over time.
Measured: 1 Year
Secondary outcomes (2)
Differences in Gene Expressions From Surgically Resected Tissue in Comparison To Those Associated With EMT.
A digital spatial transcriptomic analysis will be performed to evaluate unbiased, global gene expression changes beyond those related to EMT. This analysis will focus specifically on the materials used in the biopsy-site markers and their relative stiffness. In parallel, we will assess whether the stiffness of the implanted markers is associated with the development of an anti-inflammatory tumor microenvironment.
Measured: 1 Year
Number of Different Variations In Gene Expression From Surgically Resected Tissue Samples.
Using spatial transcriptomic technology, we will assess variations in gene expression within surgically resected tissue and compare these profiles to baseline gene expression levels observed in adjacent normal tissue.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start9 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2030 (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.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Takemi Tanaka, PhD, Principal investigator, University of Oklahoma - Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833566
- Sponsor's protocol ID
- OU-SCC-MOSAIC
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Biopsy-site-marker in Breast Cancer (MOSAIC)
- ClinicalTrials.gov ID
- NCT07833566
- Acronym / sponsor ID
- OU-SCC-MOSAIC
- Conditions
- Breast Cancer
- Keywords
- Biopsy Site Marker, Lumpectomy, Mastectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 22 Sep 2026 (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.
The purpose of this study is to explore pro-metastatic changes in breast cancer (BC) associated with the stiffness of biopsy site markers. This study aims to determine whether the stiffness of a biopsy site marker promotes inflammatory changes in breast cancer and to evaluate whether there is a relationship between biopsy site marker stiffness and inflammation.
Detailed description
This prospective study aims to evaluate whether anti-inflammatory and pro-metastatic changes at the post-biopsy site are associated with the type of biopsy-site marker used, with particular focus on marker stiffness. Tissue samples will be collected from breast cancer patients who received a biopsy-site marker at the time of diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | – | Device: Biopsy-Site Marker Placement.140 patients will be assigned to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received biopsy-site marker during diagnosis outside the OUBI OKC campus and were referred to OUBI for surgery as the first definitive treatment.
Key inclusion criteria (3 listed)
- Written informed consent (ICF) signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses.
- Female patients at > 18 years of age at the time of signature of the ICF.
- Pathologically verified invasive breast cancer cases referred to OU for surgery.
Key exclusion criteria (6 listed)
- Patients who had a biopsy at OUBI OKC.
- Patient who will undergo neoadjuvant therapy
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active viral infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
- Currently pregnant or breastfeeding
- Patients not eligible for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy-Site Marker Placement.Tissue samples will be collected from Breast Cancer patients, stages I-III, who underwent lumpectomy (mastectomy) after biopsy site marker placement during image-guided biopsy. | Device | Breast Cancer Patients |
Primary outcome
Proportion of Patients With Evaluable Tissue Samples.
Time frame: 1 year
To process 100 surgically resected breast tumors that had needle biopsy and biopsy site marker placement outside OKC downtown campus.
Differences in Stiffness of Tissue Samples Collected During Surgical Biopsy.
Time frame: 1 Year
We will conduct a spatiotemporal analysis of surgically resected tissues to evaluate whether the stiffness of the chemical materials is associated with an anti-inflammatory microenvironment and a higher prevalence of epithelial-mesenchymal transition (EMT) in cancer cells. To better characterize these differences, we will assess phenotypic changes using multiplex immunofluorescence on resected surgical specimens with the biopsy site marker in place, enabling precise spatial localization and comparison of tissue responses over time.
2 secondary outcomes
Differences in Gene Expressions From Surgically Resected Tissue in Comparison To Those Associated With EMT.
Time frame: 1 Year
Number of Different Variations In Gene Expression From Surgically Resected Tissue Samples.
Time frame: 1 Year
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 22 Sep 2026.
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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.
Takemi Tanaka, PhD contact
Takemi Tanaka, PhD principal investigator
University of Oklahoma - Stephenson Cancer Center
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, run by University of Oklahoma at 1 site in United States.
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 3 inclusion and 6 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 22 Sep 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 United States. 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 Lead Onco Nurse (405-271-8777, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Evaluable Tissue Samples. (time frame: 1 year). 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 22 Sep 2026.