[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05561842":3,"trial-entities:NCT05561842":154,"trial-summary:NCT05561842":158},{"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":25,"primary_purpose":15,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":15,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":54,"locations":57,"central_contacts":139,"overall_officials":146,"references":150,"see_also_links":151},"NCT05561842","21-325","Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)","Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria","RECRUITING","2027-09-21","2025-10","2025-10-14","2022-09-21","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies. Researchers will use mHealth devices to create a sustainable and practical way of training radiologists in Nigeria to perform and clinically implement US-guided breast biopsies into their practice.",[18,19],"Breast Cancer","Breast Cancer Female",[21,22,23,24,5,13],"breast ultrasound","breast cancer","breast biopsy","breast cancer diagnosis","OBSERVATIONAL",[],{"count":28,"type":29},900,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"PROCEDURE","mHealth US-breast biopsy","During this study, women will undergo an US-guided breast biopsy by a radiologist instead of what is typically performed in Nigerian hospitals, which is either a blind biopsy or surgical excision. US-guided breast biopsy is the standard of care in the United States of America because the accuracy is better than blind biopsy and equal to surgical excision.",[36],"Participants with a solid mass on breast ultrasound",[38],{"measure":39,"description":40,"timeFrame":41},"Number of successful US-guided breast biopsy","Trainees will be evaluated using a passing criterion of 80% on a validated test that assesses competency based on the The Ottawa Surgical Competency Operating Room Evaluation (O-Score). There are 8 variables rated on a scale of 1-5. A trainee will be given a passing grade if the responses on all 8 variables are 4 or 5 and this is achieved in at least 80% of the unsupervised simulation and patient biopsies.","1 year",[],"FEMALE","18 Years",false,{"inclusion":47,"exclusion":50,"raw_text":53},[48,49],"Age 18 and older female.","Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.",[51,52],"Participants unwilling to sign consent.","Participants under the age of 18.","Inclusion Criteria:\n\n* Age 18 and older female.\n* Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.\n\nExclusion Criteria:\n\n* Participants unwilling to sign consent.\n* Participants under the age of 18.",[55,56],"ADULT","OLDER_ADULT",[58,71,84,92,104,111,122,133],{"facility":59,"status":8,"city":60,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":68},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","New York","10065","United States",[64],{"name":65,"role":66,"phone":67},"Elizabeth Sutton, MD","CONTACT","646-888-5455",{"lat":69,"lon":70},40.71427,-74.00597,{"facility":72,"status":8,"city":73,"state":74,"country":75,"contacts":76,"geoPoint":81},"Lagos University Teaching Hospital","Idi Araba","Lagos","Nigeria",[77],{"name":78,"role":66,"phone":79,"email":80},"Olubukola Omidiji, MD","08122167403","olubukolaomidiji@yahoo.com",{"lat":82,"lon":83},6.52028,3.35382,{"facility":85,"status":86,"city":87,"state":88,"country":75,"geoPoint":89},"Olabisis Onabanjo University Teaching Hospital (Data Collection Only)","ACTIVE_NOT_RECRUITING","Sagamu","Ogun State",{"lat":90,"lon":91},6.8485,3.64633,{"facility":93,"status":8,"city":94,"state":95,"country":75,"contacts":96,"geoPoint":101},"Federal Medical Centre Owo (Data Collection Only)","Owo","Ondo State",[97],{"name":98,"role":66,"phone":99,"email":100},"Adedeji Egberongbe, MD","08034714382","deji_egbe@yahoo.com",{"lat":102,"lon":103},7.1962,5.58681,{"facility":105,"status":86,"city":106,"state":107,"country":75,"geoPoint":108},"University College Hospital (Data Collection Only)","Ibadan","Oyo State",{"lat":109,"lon":110},7.37756,3.90591,{"facility":112,"status":8,"city":113,"country":75,"contacts":114,"geoPoint":119},"University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu","Enugu",[115],{"name":116,"role":66,"phone":117,"email":118},"Nneka Iloanusi, MD","08033143023","nneka.iloanusi@unn.edu.ng",{"lat":120,"lon":121},6.44132,7.49883,{"facility":123,"status":8,"city":124,"country":75,"contacts":125,"geoPoint":130},"Obafemi Awolowo University Teaching Hospitals Complex (Data Collection Only)","Ile-Ife",[126],{"name":127,"role":66,"phone":128,"email":129},"Adeleye Omisore, MD","+2348031538004","omisoreadeleye@yahoo.com",{"lat":131,"lon":132},7.4824,4.56032,{"facility":134,"status":86,"city":135,"country":75,"geoPoint":136},"University of Ilorin Teaching Hospitals","Ilorin",{"lat":137,"lon":138},8.49664,4.54214,[140,142],{"name":65,"role":66,"phone":67,"email":141},"suttone@mskcc.org",{"name":143,"role":66,"phone":144,"email":145},"Yolana Bryce, MD","212-639-6530","brycey@mskcc.org",[147],{"name":148,"affiliation":13,"role":149},"Eliabeth Sutton, MD","PRINCIPAL_INVESTIGATOR",[],[152],{"label":13,"url":153},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":155,"biomarkers":157},[156],"Breast Carcinoma",[],{"nct_id":4,"found":159,"summary":160,"prompt_version":170},true,{"design":161,"status":162,"heading":163,"summary":164,"follow_up":165,"word_count":166,"commitments":167,"compensation":168,"drugs_mentioned":169},"This is an observational study with a planned enrollment of 900 women. It is not specified if it's randomized or blinded.","completed","Mobile Health Ultrasound for Breast Cancer Diagnosis in Nigeria","This study is looking at a new way to diagnose breast cancer in Nigeria using a procedure called US-guided breast biopsy (ultrasound-guided breast biopsy). This method uses ultrasound to guide the biopsy, which is a standard practice in the United States. The study aims to train Nigerian radiologists to perform these biopsies using mobile health (mHealth) devices. You may be able to join if you are an adult woman (18 years or older) with a breast ultrasound showing a solid mass that doctors suspect might be cancer. The main goal is to see how many successful US-guided breast biopsies are performed over one year. The current recruitment status is unclear.","The primary outcome, successful US-guided breast biopsies, will be measured at 1 year.",110,"If you participate, you will undergo an US-guided breast biopsy performed by a trained radiologist.","Not stated in the trial record.",[],"v2"]