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Biopsy-site-marker in Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Breast Cancer Patients1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 Year

Secondary outcomes

1

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.

Time frame
1 Year
2

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.

Time frame
1 Year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Source ClinicalTrials.gov
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