[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02743858":3,"trial-entities:NCT02743858":156,"trial-summary:NCT02743858":160},{"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":15,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":15,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":48,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":15,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":71,"locations":74,"central_contacts":147,"overall_officials":150,"references":152,"see_also_links":153},"NCT02743858","16-220","Lymphedema Surveillance Study","A Prospective Surveillance Program for Assessment and Treatment of Breast Cancer-Related Lymphedema After Axillary Lymph Node Dissection","RECRUITING","2027-04","2026-05","2026-05-07","2016-04","Memorial Sloan Kettering Cancer Center","OTHER",null,"This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. The investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.",[18,19],"Breast Cancer","Lymphedema",[19,21,22,5],"Surveillance Program","Axillary Lymph Node Dissection","OBSERVATIONAL",[],{"count":26,"type":27},1250,"ESTIMATED",[29,36,40,44],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Bilateral arm measurements","Pts treated with ALND, bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) circumferential arm measurements with elastic tape taken at 4-cm intervals from the wrist to the shoulder \\& the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. Measurements will be performed before surgery, post-operatively \\& at timepoints of 6,12,18, \\& 24 months after surgery for 2 years will be obtained using the Perometer (Model 350 NT Perometer, Per-System) for bioimpedance measurements. Pts who have not yet developed lymphedema by 2 years, an additional measurement at approx 3 years post-surgery will be performed. If pt is diag with lymphedema at the 3-year visit, she will be asked to continue on study for an additional year. Pts treated with SLNB alone, following re-consent, a long-term follow-up volumetric arm measurement will be obtained using the perometer \\& circumferential arm measurements at a minimum of 2 years post-surgery.",[33,34,35],"ALND Translational Study Patients","Patients treated with SLNB alone","Patients who consent for ALND",{"type":14,"name":37,"description":38,"armGroupLabels":39},"Body mass index (BMI)","Height and weight will be obtained for each patient at baseline and at each scheduled visit for the purpose of calculating BMI. BMI will be correlated with the presence of inflammatory biomarkers in the tissue, as well as with lymphedema development.",[33,34,35],{"type":41,"name":42,"armGroupLabels":43},"BEHAVIORAL","Quality of Life Questionnaire",[33,34,35],{"type":14,"name":45,"description":46,"armGroupLabels":47},"Blood draw","Patients enrolled in the translational study (Cohort 3) will undergo blood draws for serum collection preoperatively and 12-24 months postoperatively to test for FGF2, IL4, IL10, TGFB, Leptin, IL6, and CRP. At both timepoints, up to 20 mL of blood will be collected.",[33],[49],{"measure":50,"description":51,"timeFrame":52},"number of incidences of lymphedema","as defined by perometry using rigorous measurement protocols. Bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) and the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements.","2 year",[],"FEMALE","18 Years",false,{"inclusion":58,"exclusion":64,"raw_text":70},[59,60,61,62,63],"Female breast cancer patients over the age of 18","Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if \\\u003C6 months from consent)","Patients consenting for unilateral sentinel lymph node biopsy (SLNB) and possible ALND are eligible for initial entry into the study, but will become ineligible if ALND is not performed","Initially consented patients, treated with SLNB alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment","Patients who self-identify as Black or White consenting for unilateral ALND or possible ALND will be approached for enrollment onto translational study (Cohort 3)",[65,66,67,68,69],"Male breast cancer patients","Patients consenting for bilateral axillary surgery","Patients with prior history of surgical excision of one or more axillary lymph nodes or SLNB, performed \\>6 months from date of consent","Patients with prior history of ALND","Patients with no breast surgery performed at MSK","Inclusion Criteria:\n\n* Female breast cancer patients over the age of 18\n* Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if \\\u003C6 months from consent)\n* Patients consenting for unilateral sentinel lymph node biopsy (SLNB) and possible ALND are eligible for initial entry into the study, but will become ineligible if ALND is not performed\n* Initially consented patients, treated with SLNB alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment\n* Patients who self-identify as Black or White consenting for unilateral ALND or possible ALND will be approached for enrollment onto translational study (Cohort 3)\n\nExclusion Criteria:\n\n* Male breast cancer patients\n* Patients consenting for bilateral axillary surgery\n* Patients with prior history of surgical excision of one or more axillary lymph nodes or SLNB, performed \\>6 months from date of consent\n* Patients with prior history of ALND\n* Patients with no breast surgery performed at MSK",[72,73],"ADULT","OLDER_ADULT",[75,89,98,107,117,126,138],{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":86},"Memorial Sloan Kettering Basking Ridge (Consent only)","Basking Ridge","New Jersey","07920","United States",[82],{"name":83,"role":84,"phone":85},"Andrea Barrio, MD","CONTACT","646-888-5117",{"lat":87,"lon":88},40.70621,-74.54932,{"facility":90,"status":8,"city":91,"state":78,"zip":92,"country":80,"contacts":93,"geoPoint":95},"Memorial Sloan Kettering Monmouth (Consent only)","Middletown","07748",[94],{"name":83,"role":84,"phone":85},{"lat":96,"lon":97},40.39428,-74.11709,{"facility":99,"status":8,"city":100,"state":78,"zip":101,"country":80,"contacts":102,"geoPoint":104},"Memorial Sloan Kettering Bergen (Consent only)","Montvale","07645",[103],{"name":83,"role":84,"phone":85},{"lat":105,"lon":106},41.04676,-74.02292,{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":80,"contacts":112,"geoPoint":114},"Memorial Sloan Kettering Commack (Consent only)","Commack","New York","11725",[113],{"name":83,"role":84,"phone":85},{"lat":115,"lon":116},40.84288,-73.29289,{"facility":118,"status":8,"city":119,"state":110,"zip":120,"country":80,"contacts":121,"geoPoint":123},"Memorial Sloan Kettering Westchester (Consent only)","Harrison","10604",[122],{"name":83,"role":84,"phone":85},{"lat":124,"lon":125},40.96899,-73.71263,{"facility":13,"status":8,"city":110,"state":110,"zip":127,"country":80,"contacts":128,"geoPoint":135},"10065",[129,130,133],{"name":83,"role":84,"phone":85},{"name":131,"role":84,"phone":132},"Babak Mehrara, MD","212-639-8639",{"name":83,"role":134},"PRINCIPAL_INVESTIGATOR",{"lat":136,"lon":137},40.71427,-74.00597,{"facility":139,"status":8,"city":140,"state":110,"zip":141,"country":80,"contacts":142,"geoPoint":144},"Memorial Sloan Kettering Nassau (Consent only)","Uniondale","11553",[143],{"name":83,"role":84,"phone":85},{"lat":145,"lon":146},40.70038,-73.59291,[148,149],{"name":83,"role":84,"phone":85},{"name":131,"role":84,"phone":132},[151],{"name":83,"affiliation":13,"role":134},[],[154],{"label":13,"url":155},"https:\u002F\u002Fwww.mskcc.org\u002F",{"nct_id":4,"conditions":157,"biomarkers":159},[158],"Breast Carcinoma",[],{"nct_id":4,"found":161,"summary":162,"prompt_version":172},true,{"design":163,"status":164,"heading":165,"summary":166,"follow_up":167,"word_count":168,"commitments":169,"compensation":170,"drugs_mentioned":171},"This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It aims to enroll 1250 women.","completed","Lymphedema Surveillance Study for Breast Cancer Patients","This observational study is looking at how many women develop lymphedema (swelling caused by fluid buildup) after breast cancer surgery that involves removing lymph nodes from the armpit (axillary lymph node dissection). Researchers also want to understand why some women get lymphedema and others don't. They will measure your arms using a Perometer and L-Dex U400, calculate your Body Mass Index (BMI), and ask you to complete a Quality of Life Questionnaire. Some participants will also have blood drawn before and after surgery to look for certain markers. The study aims to see if detecting inflammation in breast tissue can help predict lymphedema risk and if earlier detection can improve outcomes. This study is for women aged 18 and older who are having breast cancer surgery involving lymph node removal. The main goal is to count how many cases of lymphedema occur over two years.","The primary outcome, the number of lymphedema cases, will be measured at two years.",145,"You will have arm measurements, height and weight taken at baseline and scheduled visits. You will also complete a Quality of Life Questionnaire. Some participants will have up to 20 mL of blood drawn before surgery and 12-24 months after.","Not stated in the trial record.",[37,42,45],"v2"]