[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566290":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":62,"collaborators":64,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":10,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":10,"enrollmentInfo":80,"targetDuration":10,"studyType":83,"phases":10,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":92,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Centro de Excelencia en Enfermedades de Cabeza y Cuello","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bethesda IV-VI report",null,"thyroid nodules who underwent FNAC with a Bethesda IV-VI report",[13],"Other: Active surveillance",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Active surveillance","a non-operative management strategy aimed at avoiding unnecessary surgery in patients with thyroid nodules with a cytopathological diagnosis of Bethesda IV-VI, who do not present clinical or imaging characteristics suggesting malignancy and\u002For aggressiveness.",[9],[20],{"name":21,"affiliation":22,"role":23},"Alvaro Sanabria","Universidad de Antioquia","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Alvaro Sanabria, Md, MSc, PhD","CONTACT","+57 60443113780","alvarosanabria@gmail.com",[31,44,49,54],{"facility":32,"status":10,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":10},"Hospital Alma Mater de Antoquia","Medellín","Antioquia","050010","Colombia","CO",{"type":39,"coordinates":40},"Point",[41,42],-75.57151,6.245,{"lat":42,"lon":41},{"facility":45,"status":10,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":46,"geoPoint":48,"contacts":10},"Hospital San Vicente Fundacion",{"type":39,"coordinates":47},[41,42],{"lat":42,"lon":41},{"facility":22,"status":10,"city":33,"state":10,"zip":50,"country":36,"countryCode":37,"cosmosGeoPoint":51,"geoPoint":53,"contacts":10},"050021",{"type":39,"coordinates":52},[41,42],{"lat":42,"lon":41},{"facility":55,"status":10,"city":56,"state":10,"zip":10,"country":36,"countryCode":37,"cosmosGeoPoint":57,"geoPoint":61,"contacts":10},"Clinica Somer","Rionegro",{"type":39,"coordinates":58},[59,60],-75.37371,6.15515,{"lat":60,"lon":59},{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[65,68,70],{"name":66,"class":67},"Hospital Alma Mater de Antioquia","UNKNOWN",{"name":69,"class":6},"Hospital San Vicente Fundación",{"name":55,"class":67},"100566290","active-surveillance-program-in-thyroid-nodules-100566290",false,"NCT06653257","Active Surveillance Program in Thyroid Nodules","Outcomes of a 5-Year Active Surveillance Program in Bethesda IV-VI Thyroid Nodules","Inclusion Criteria:\n\n1. Patients with thyroid nodules and FNAC with a report corresponding to Bethesda category IV-VI, treated at the following health centers: HUSVF, HAMA, Center of Excellence in Head and Neck Diseases - CEXCA, Somer Clinic.\n2. Patients classified as low-risk tumors (intrathyroidal, with no evidence of locoregional or distant metastasis).\n3. Patients not subjected to thyroidectomy as the initial treatment.\n\nExclusion Criteria:\n\n* 1\\. Patients with a second head and neck cancer. 2. Patients with clinical or imaging evidence of thyroid malignancy with lymph node or distant metastasis confirmed by pathology.","ALL","18 Years",{"count":81,"type":82},300,"ESTIMATED","OBSERVATIONAL","Overview This study focuses on thyroid nodules, specifically the Bethesda IV-VI categories, which have uncertain or suspicious malignancy. The idea is to observe and monitor these nodules instead of opting for immediate surgery, a practice known as active surveillance. The main goal of active surveillance is to avoid unnecessary surgeries, which can lead to complications like nerve damage or hypoparathyroidism.\n\nProblem and Objectives Thyroid nodules in these Bethesda categories can be cancerous, but not all require immediate removal. Active surveillance tracks nodule growth and other changes using regular ultrasounds and clinical checkups. This approach is gaining popularity, especially in Japan, Europe, and the U.S., but there's still a need for more data, particularly in Latin America.\n\nThe primary objectives of the study are:\n\nGeneral: To describe the clinical and imaging characteristics of patients with Bethesda IV-VI nodules under active surveillance.\n\nSpecific: To measure surgery rates, reasons for surgery, and how long patients can avoid surgery.\n\nMethodology This study is a multicenter historical cohort study, which will look at patients treated from 2019 to 2023 in different hospitals. Patients included in the study are those with Bethesda IV-VI thyroid nodules, who are over 18 and have been managed without immediate thyroid surgery. Data will be collected from medical records and imaging reports, and patients will be followed up to document any changes in their nodules, including growth or metastasis.\n\nExpected Impact The study aims to determine whether active surveillance can safely delay or avoid surgery for selected patients. It could have a significant impact on clinical decision-making, improving patient outcomes and reducing unnecessary surgeries, especially within the Colombian healthcare system. If successful, this approach could reduce costs and improve the quality of life for patients with thyroid nodules.\n\nEthical Considerations The study will follow ethical guidelines, ensuring patient confidentiality and classifying the research as \"no-risk,\" meaning it involves minimal risk to the participants.",[86],"Thyroid Nodule",[88,89,90,91],"thyroid","nodule","bethesda","active surveillance","NOT_YET_RECRUITING","2024-10-27",{"date":95,"type":96},"2024-10-29","ACTUAL",{"date":98,"type":82},"2024-11-01",{"date":100,"type":82},"2026-07-01",{"name":5,"class":6},4]