[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07725172":3,"trial-entities:NCT07725172":130,"trial-summary:NCT07725172":134},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":40,"secondary_outcomes":74,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":15,"eligibility_criteria":78,"std_ages":91,"locations":93,"central_contacts":118,"overall_officials":123,"references":128,"see_also_links":129},"NCT07725172","Pro00120784","Radiation Therapy and Thymus Function in Young Women With Breast Cancer","Off-Target Effects of Breast Cancer Adjuvant Radiation Therapy on Thymus Function in Young Women","NOT_YET_RECRUITING","2029-09","2026-07","2026-07-24","2026-09","Duke University","OTHER",false,"Breast cancer treatment sometimes includes radiation to the breast or chest wall. There is a small gland, called the thymus, located in the upper chest that may receive a small amount of the radiation aimed at the breast. The goal of this study is to collect blood samples from young women with breast cancer to study the effect of radiation therapy on the thymus gland.","This study includes participants whose plan of care may or may not include radiation therapy.\n\n* Participants whose plan of care includes radiation therapy will have about three teaspoons of research blood collected at the following time points:\n\n  * Before the start of radiation therapy\n  * At the end of radiation therapy\n  * About six months after completing radiation therapy\n* Participants whose plan of care does NOT include radiation therapy will have about three teaspoons of research blood collected at the following timepoints:\n\n  * After surgery (up to three months after surgery)\n  * About 8 months after the first research blood collection",[19],"Breast Cancer",[21,22,23,24,25],"breast cancer in young women","blood collection","thymopoesis","thymus","radiation therapy","OBSERVATIONAL",null,[],{"count":30,"type":31},125,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"PROCEDURE","Blood draw for the laboratory assessment","Blood will be drawn and processed for Peripheral Blood Mononuclear Cells (PBMCs). PBMC biomarkers will be used to assess thymopoiesis .",[38,39],"No Radiation Therapy","Radiation Therapy",[41,45,47,49,52,54,57,59,61,64,65,68,70,72],{"measure":42,"description":43,"timeFrame":44},"Level of signal joint T cell Receptor Exclusion Circles (sjTREC) in peripheral blood T cells","As measured by quantitative PCR in participants receiving radiotherapy (RT)","baseline",{"measure":42,"description":43,"timeFrame":46},"at the end of RT, about 5 weeks",{"measure":42,"description":43,"timeFrame":48},"6 months post-RT",{"measure":42,"description":50,"timeFrame":51},"As measured by quantitative PCR in participants NOT receiving radiotherapy (RT)","within 3 months after breast cancer surgery",{"measure":42,"description":50,"timeFrame":53},"approximately 8-11 months after breast cancer surgery",{"measure":55,"description":56,"timeFrame":44},"Level of CD4+ recent thymic emigrant (RTE) cells in participant blood samples","As measured by flow cytometry in blood from participants receiving radiotherapy (RT)",{"measure":58,"description":56,"timeFrame":46},"Level of CD4+ RTE cells in participant blood samples",{"measure":58,"description":56,"timeFrame":60},"6 months post RT",{"measure":58,"description":62,"timeFrame":63},"As measured by flow cytometry in blood from participants NOT receiving radiotherapy (RT)","within 3 months of breast cancer surgery",{"measure":58,"description":62,"timeFrame":53},{"measure":66,"description":67,"timeFrame":60},"Effect of adjuvant radiotherapy treatment dose on levels of sjTREC-containing T cells","using a linear mixed-effect model in participants receiving RT",{"measure":69,"description":67,"timeFrame":60},"Effect of adjuvant radiotherapy treatment fractionation on levels of sjTREC-containing T cells",{"measure":71,"description":67,"timeFrame":60},"Effect of adjuvant radiotherapy treatment fractionation on levels of CD4+ RTE cells",{"measure":73,"description":67,"timeFrame":60},"Effect of adjuvant radiotherapy treatment dose on levels of CD4+ RTE cells",[],"FEMALE","18 Years","50 Years",{"inclusion":79,"exclusion":84,"raw_text":90},[80,81,82,83],"Women aged 18 to 50 undergoing mastectomy or breast-conserving surgery for breast cancer of any subtype at DUMC and associated satellite centers","Histologic documentation of breast cancer based on pathology","Systemic therapies including hormone therapy, targeted therapy, chemotherapy and immunotherapy as given for breast cancer treatment at the discretion of the treating medical oncologist are allowed and use of such therapies will be documented and included as a covariate","Willing and able to provide written informed consent",[85,86,87,88,89],"Prior history of therapeutic high-dose irradiation of the thorax (e.g. for treatment of lung cancer, head\u002Fneck cancer, Hodgkin disease, etc., not just radiological imaging alone)","History of thymectomy or treatment with immunosuppressive drugs within the past six months","Individuals with rheumatoid arthritis or other autoimmune conditions","Individuals with Down's syndrome","Male patients","Inclusion Criteria:\n\n* Women aged 18 to 50 undergoing mastectomy or breast-conserving surgery for breast cancer of any subtype at DUMC and associated satellite centers\n* Histologic documentation of breast cancer based on pathology\n* Systemic therapies including hormone therapy, targeted therapy, chemotherapy and immunotherapy as given for breast cancer treatment at the discretion of the treating medical oncologist are allowed and use of such therapies will be documented and included as a covariate\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Prior history of therapeutic high-dose irradiation of the thorax (e.g. for treatment of lung cancer, head\u002Fneck cancer, Hodgkin disease, etc., not just radiological imaging alone)\n* History of thymectomy or treatment with immunosuppressive drugs within the past six months\n* Individuals with rheumatoid arthritis or other autoimmune conditions\n* Individuals with Down's syndrome\n* Male patients",[92],"ADULT",[94],{"facility":95,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":115},"Duke Cancer Center","Durham","North Carolina","27710","United States",[101,106,110,113],{"name":102,"role":103,"phone":104,"email":105},"Eileen Duffy, RN OCN","CONTACT","919-668-3726","eileen.duffy@duke.edu",{"name":107,"role":103,"phone":108,"email":109},"Linda Kaltenbach, PhD","(919) 668-3726","Linda.Kaltenbach@duke.edu",{"name":111,"role":112},"Susan McDuff, MD PhD","PRINCIPAL_INVESTIGATOR",{"name":114,"role":112},"Andrew Macintyre, PhD",{"lat":116,"lon":117},35.99403,-78.89862,[119],{"name":120,"role":103,"phone":121,"email":122},"Duke Radiation Oncology Clinical Trials","(919 668-3726","RadOnc-Clinical_Trials@dm.duke.edu",[124,126],{"name":111,"affiliation":125,"role":112},"Duke University Health System (DUHS)",{"name":114,"affiliation":127,"role":112},"Duke Human Vaccine Institute",[],[],{"nct_id":4,"conditions":131,"biomarkers":133},[132],"Breast Carcinoma",[],{"nct_id":4,"found":135,"summary":136,"prompt_version":145},true,{"design":137,"status":138,"heading":6,"summary":139,"follow_up":140,"word_count":141,"commitments":142,"compensation":143,"drugs_mentioned":144},"This is an observational study involving 125 young women with breast cancer. It is not testing a new treatment, but rather observing the effects of standard care.","completed","This study is looking at how radiation therapy for breast cancer might affect a small gland in your chest called the thymus. The thymus plays a role in your immune system. Researchers will collect blood samples from young women (ages 18-50) with breast cancer who are having surgery, whether or not they receive radiation therapy. They will measure specific markers in your blood called sjTREC (signal joint T cell Receptor Exclusion Circles) at different times to see if radiation therapy changes them. This study aims to understand the impact of radiation on the thymus. The study plans to enroll 125 participants.","Participants will be followed for about six months after completing radiation therapy, or about 8 months after the first blood collection if not receiving radiation.",101,"You would have about three teaspoons of blood drawn at specific times: before, during, and after radiation therapy, or after surgery and then about 8 months later if you don't receive radiation.","Not stated in the trial record.",[],"v2"]