[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04022616":3,"trial-entities:NCT04022616":89,"trial-summary:NCT04022616":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":6,"detailed_description":15,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":15,"phases":20,"enrollment_info":21,"interventions":24,"primary_outcomes":33,"secondary_outcomes":38,"sex":48,"minimum_age":49,"maximum_age":15,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":58,"locations":61,"central_contacts":70,"overall_officials":76,"references":80,"see_also_links":85},"NCT04022616","OSU-09142","Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients","RECRUITING","2027-12-31","2026-04","2026-04-06","2010-06-04","Ohio State University Comprehensive Cancer Center","OTHER",false,null,[17],"Breast Cancer",[],"OBSERVATIONAL",[],{"count":22,"type":23},99,"ESTIMATED",[25],{"type":13,"name":26,"description":27,"armGroupLabels":28},"Specimen collection","Specimens are obtained from patients who are being treated for breast malignancies.",[29,30,31,32],"Immediate Surgery","Lymph Node Tissue","Metastatic Breast Cancer","Neo-adjuvant Chemotherapy",[34],{"measure":35,"description":36,"timeFrame":37},"Isolate unfavorable immune cells MDSC from the peripheral blood or tumors of study subjects and test how strongly they inhibit function of favorable immune cells called Natural Killer Cells.","Function of Natural Killer Cells will be studied by measuring their ability to kill target cancer cells coated with monoclonal antibodies.\n\nisolate unfavorable immune cells called Myeloid Derived Suppressor Cells (MDSC) from the peripheral blood or the tumors of study subjects and test how strongly they inhibit function of favorable immune cells called Natural Killer Cells. Function of Natural Killer Cells will be studied by measuring their ability to kill target cancer cells coated with monoclonal antibodies.","up to 1 year",[39,42,45],{"measure":40,"description":41,"timeFrame":37},"Isolate unfavorable immune cells called Myeloid Derived Suppressor Cells (MDSC) from the peripheral blood of study subjects who plan to start pre-operative chemotherapy for breast cancer to see if MDSC levels can predict who will respond to treatment. W","Percentage of MDSC at baseline and whether there is an association of baseline MDSC percent with response to chemotherapy.",{"measure":43,"description":44,"timeFrame":37},"Isolate unfavorable immune cells MDSC from peripheral blood of study subjects who receive pre-operative chemotherapy for breast cancer to identify changes in MDSC levels during treatment can predict who will respond to treatment.","Changes will be reported in percentage of MDSC and associations of such changes with response to chemotherapy.",{"measure":46,"description":47,"timeFrame":37},"Isolate lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present.","Isolate a lymph nodes from patients with breast cancer undergoing breast surgery to study what types of Natural Killer Cells are present. Natural Killer cells are immune cells that are capable of killing cancer cells.","FEMALE","18 Years",{"inclusion":51,"exclusion":55,"raw_text":57},[52,53,54],"18 years of age or older","Ability to give informed consent","Stage I-III breast malignancy",[56],"Unable to tolerate venipuncture","Inclusion Criteria:\n\n* 18 years of age or older\n* Ability to give informed consent\n* Stage I-III breast malignancy\n\nExclusion Criteria:\n\n* Unable to tolerate venipuncture",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":12,"status":7,"city":63,"state":64,"zip":65,"country":66,"geoPoint":67},"Columbus","Ohio","43210","United States",{"lat":68,"lon":69},39.96118,-82.99879,[71],{"name":72,"role":73,"phone":74,"email":75},"Ohio State Comprehensive Cancer Center","CONTACT","1-800-293-5066","OSUCCCClinicaltrials@osumc.edu",[77],{"name":78,"affiliation":72,"role":79},"William Carson, MD","PRINCIPAL_INVESTIGATOR",[81],{"pmid":82,"type":83,"citation":84},"32429929","DERIVED","Wesolowski R, Stiff A, Quiroga D, McQuinn C, Li Z, Nitta H, Savardekar H, Benner B, Ramaswamy B, Lustberg M, Layman RM, Macrae E, Kassem M, Williams N, Sardesai S, VanDeusen J, Stover D, Cherian M, Mace TA, Yu L, Duggan M, Carson WE 3rd. Exploratory analysis of immune checkpoint receptor expression by circulating T cells and tumor specimens in patients receiving neo-adjuvant chemotherapy for operable breast cancer. BMC Cancer. 2020 May 19;20(1):445. doi: 10.1186\u002Fs12885-020-06949-4.",[86],{"label":87,"url":88},"The Jamesline","http:\u002F\u002Fcancer.osu.edu",{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Breast Carcinoma",[],{"nct_id":4,"found":94,"summary":95,"prompt_version":104},true,{"design":96,"status":97,"heading":6,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an observational study planning to enroll 99 participants. It does not involve a specific treatment intervention.","completed","This observational study is looking at immune cells called Myeloid-Derived Suppressor Cells (MDSCs) in people with breast cancer. Researchers want to understand how these MDSCs, which are considered \"unfavorable\" immune cells, might stop \"favorable\" immune cells called Natural Killer Cells from working properly. You might be able to join if you are 18 or older, can give informed consent, and have Stage I-III breast cancer. The study involves collecting specimens from you. The goal is to see how strongly MDSCs inhibit Natural Killer Cells, with measurements taken for up to one year. The study plans to enroll 99 participants, but its current status is unclear.","The primary endpoint is measured for up to one year.",105,"You would provide specimens, which are obtained from patients being treated for breast cancer.","Not stated in the trial record.",[],"v2"]