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NCT Number: NCT07833566

Biopsy-site-marker in Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Differences in Gene Expressions From Surgically Resected Tissue in Comparison To Those Associated With EMT.

    Time frame: 1 Year

    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.

  2. Number of Different Variations In Gene Expression From Surgically Resected Tissue Samples.

    Time frame: 1 Year

    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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Inflammation and Biopsy-site-marker in Breast Cancer (MOSAIC)

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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