[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594925":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":24,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":24,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1:Non African American","EXPERIMENTAL","50 Non-African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes).",[13],"Diagnostic Test: Circulating tumor DNA",{"label":15,"type":10,"description":16,"interventionNames":17},"2: African American","50 African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Circulating tumor DNA","Circulating tumor DNA (ctDNA) is a noninvasive prognostic biomarker for disease monitoring. ). Blood collection for ctDNA testing will be performed at the time of enrollment (prior to initiation of adjuvant therapy), and every three months thereafter.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Yara Abdou, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Timothy H Wilkinson","CONTACT","919-445-4872","timothy_wilkinson@med.unc.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Chapel Hill","North Carolina","27514","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-79.05584,35.9132,{"lat":47,"lon":46},[50,54,57],{"name":51,"role":32,"phone":52,"phoneExt":24,"email":53},"Mireille Leone","919-984-0000","mireille_leone@med.unc.edu",{"name":55,"role":32,"phone":24,"phoneExt":24,"email":56},"Paige Stem","paige_stem@med.unc.edu",{"name":27,"role":28,"phone":24,"phoneExt":24,"email":24},{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[61],{"name":62,"class":63},"Haystack Oncology, Inc.","UNKNOWN","100594925","molecular-residual-disease-assessment-in-a-representative-diverse-population-of-patients-with-early-stage-breast-cancer-100594925",false,"NCT07025785","Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer","In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n1. Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n3. Age ≥ 18 years at time of consent.\n4. Subject must have had surgical intervention and must have sufficient archival specimens from either the primary tumor or a lymph node for ctDNA assay development, as specified in the lab manual.\n\nExclusion Criteria:\n\n1. Subjects must not have had prior neoadjuvant therapy.\n2. Evidence of metastatic disease in imaging.\n3. N1 mic or isolated tumor cells in the lymph nodes",true,"ALL","18 Years",{"count":74,"type":75},100,"ESTIMATED","INTERVENTIONAL",[78],"NA","The purpose of this study is to determine how circulating tumor DNA (ctDNA), a sign of minimal residual disease (MRD), is detectable after surgery in patients with early HR+\u002FHER2- breast cancer that has spread to 1-3 lymph nodes. Researchers aim to understand if ctDNA detection can identify patients at higher risk of recurrence and guide better treatment decisions. A key aspect is the inclusion of a dedicated cohort of African American\u002FBlack women, a group underrepresented in molecular residual disease (MRD) research despite experiencing more aggressive breast cancers. This study will correlate ctDNA results with treatment patterns (radiotherapy, systemic therapy) and outcomes (recurrence-free and overall survival) in both non-African American and African American participants.",[81,82],"Breast Cancer","Lymph Node Metastasis",[84,85,86],"circulating tumor DNA (ctDNA)","minimal residual disease (MRD)","African American","2026-01-13",{"date":89,"type":90},"2026-01-15","ACTUAL",{"date":92,"type":90},"2025-08-22",{"date":94,"type":75},"2027-08",{"name":5,"class":6},1]