[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657030":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":36,"overallOfficials":42,"centralContacts":47,"locations":55,"responsibleParty":73,"collaborators":24,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":24,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":24,"enrollmentInfo":84,"targetDuration":24,"studyType":87,"phases":24,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":58,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Oklahoma","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":16},"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",[18,21],{"measure":19,"description":20,"timeFrame":16},"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.",{"measure":22,"description":23,"timeFrame":16},"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.",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","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.","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.",[31],{"label":32,"type":24,"description":33,"interventionNames":34},"Breast Cancer Patients","140 patients will be assigned to this group.",[35],"Device: Biopsy-Site Marker Placement.",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":24},"DEVICE","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.",[32],[43],{"name":44,"affiliation":45,"role":46},"Takemi Tanaka, PhD","University of Oklahoma - Stephenson Cancer Center","PRINCIPAL_INVESTIGATOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":24,"email":52},"Lead Onco Nurse","CONTACT","405-271-8777","SCC-IIT-Office@ouhsc.edu",{"name":44,"role":50,"phone":24,"phoneExt":24,"email":54},"takemi-tanaka@ou.edu",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"OU Health Stephenson Cancer Center","RECRUITING","Oklahoma City","Oklahoma","73117","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-97.51643,35.46756,{"lat":68,"lon":67},[71],{"name":44,"role":50,"phone":24,"phoneExt":24,"email":72},"Takemi-Tanaka@ou.edu",{"type":74,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100657030","biopsy-site-marker-in-breast-cancer-100657030",false,"NCT07833566","Biopsy-site-marker in Breast Cancer","Inflammation and Biopsy-site-marker in Breast Cancer (MOSAIC)","Inclusion Criteria:\n\n* Written informed consent (ICF) signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses.\n* Female patients at \\> 18 years of age at the time of signature of the ICF.\n* Pathologically verified invasive breast cancer cases referred to OU for surgery.\n\nExclusion Criteria:\n\n* Patients who had a biopsy at OUBI OKC.\n* Patient who will undergo neoadjuvant therapy\n* 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.\n* Currently pregnant or breastfeeding\n* Patients not eligible for surgery\n* Prisoners","FEMALE","18 Years",{"count":85,"type":86},140,"ESTIMATED","OBSERVATIONAL","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.",[90],"Breast Cancer",[92,93,94],"Biopsy Site Marker","Lumpectomy","Mastectomy","2026-09-16",{"date":97,"type":98},"2026-09-22","ACTUAL",{"date":100,"type":98},"2026-07-09",{"date":102,"type":86},"2030-07",{"name":5,"class":6},1]