Clinical trial · Observational
Biopsy-site-marker in Breast Cancer
Inflammation and Biopsy-site-marker in Breast Cancer (MOSAIC)
NCT07833566CI-TRIAL-00126523recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy-Site Marker Placement. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer Patients
- description
- 140 patients will be assigned to this group.
- interventionNames
- Device: Biopsy-Site Marker Placement.
Primary outcomes (2)
- measure
- Proportion of Patients With Evaluable Tissue Samples.
- timeFrame
- 1 year
- description
- To process 100 surgically resected breast tumors that had needle biopsy and biopsy site marker placement outside OKC downtown campus.
- measure
- Differences in Stiffness of Tissue Samples Collected During Surgical Biopsy.
- timeFrame
- 1 Year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.