Recruiting

Observational Study

Sponsor:

University of Oklahoma

Code:

NCT07833566

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy-Site Marker Placement.

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT07833566

Start date

Jul 9, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Interventions and Outcome Measures

Arms

Breast Cancer Patients

140 patients will be assigned to this group.

Interventions

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.

Primary outcome measure

  • Proportion of Patients With Evaluable Tissue Samples. [ Time Frame: 1 year ]
  • Differences in Stiffness of Tissue Samples Collected During Surgical Biopsy. [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Lead Onco Nurse

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

Takemi Tanaka, PhD

takemi-tanaka@ou.edu

Locations

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

Takemi Tanaka, PhD

Takemi-Tanaka@ou.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

  • Biopsy Site Marker
  • Lumpectomy
  • Mastectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.