NCT07833566

Brief 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 biopsy site marker stiffness and inflammation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
45mo left

Started Jul 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Jul 2030

Study Start

First participant enrolled

July 9, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 16, 2026

Last Update Submit

September 16, 2026

Conditions

Breast Cancer

Keywords

Biopsy Site MarkerLumpectomyMastectomy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 Year

Secondary Outcomes (2)

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

    1 Year

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

    1 Year

Study Arms (1)

Breast Cancer Patients

140 patients will be assigned to this group.

Device: Biopsy-Site Marker Placement.

Interventions

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.

Breast Cancer Patients

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is looking at breast cancer commonly found in women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stage I-III resected tissue at the time of definitive treatment.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Takemi Tanaka, PhD

    University of Oklahoma - Stephenson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Onco Nurse

CONTACT

405-271-8777SCC-IIT-Office@ouhsc.edu

Takemi Tanaka, PhD

CONTACT

takemi-tanaka@ou.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 22, 2026

Study Start

July 9, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2030

Last Updated

September 22, 2026

Record last verified: 2026-09

Locations

US(1)