[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640816":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":48,"overallOfficials":110,"centralContacts":115,"locations":121,"responsibleParty":138,"collaborators":140,"id":144,"slug":26,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":26,"eligibilityCriteria":149,"healthyVolunteers":145,"sex":150,"minAge":151,"maxAge":26,"enrollmentInfo":152,"targetDuration":26,"studyType":155,"phases":156,"briefSummary":157,"conditions":158,"keywords":26,"overallStatus":160,"whyStopped":26,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Jonsson Comprehensive Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients who achieve biochemical remission","Will calculate the proportion of patients who achieve biochemical remission at 3 months (normal calcitonin and carcinoembryonic antigen \\[CEA\\]). Exact 95% confidence intervals will be provided. Exploratory subgroup analyses (e.g., stratified by baseline calcitonin level, tumor size, or nodal status) may be conducted to generate hypotheses but will not be powered for formal inference.","Up to 3 months",{"measure":14,"description":15,"timeFrame":16},"Proportion of patients requiring completion thyroidectomy","Completion thyroidectomy will be indicated in the setting of: Elevated or rising calcitonin and\u002For CEA plus imaging (neck ultrasound or positron emission tomography \\[PET\\]\u002Fcomputed tomography \\[CT\\]) suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes; or elevated or rising calcitonin and\u002For CEA with negative neck ultrasound and PET\u002FCT for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe. Exact 95% confidence intervals will be provided. Exploratory subgroup analyses (e.g., stratified by baseline calcitonin level, tumor size, or nodal status) may be conducted to generate hypotheses but will not be powered for formal inference.","Up to 12 months",[18,22],{"measure":19,"description":20,"timeFrame":21},"Short-term oncologic outcomes","Short-term oncologic outcomes will be categorized according to the American Thyroid Association ATA) \"response to therapy\" framework, adapted for medullary thyroid carcinoma. Categories will include: Excellent response: Normal calcitonin and CEA with no structural evidence of disease on imaging; Biochemical incomplete response: Abnormal calcitonin and\u002For CEA without structural evidence of disease; Structural incomplete response: Evidence of structural disease on imaging, regardless of biochemical status. Will be summarized descriptively. Exact 95% confidence intervals will be reported. Comparisons to baseline disease features (e.g., initial calcitonin levels, tumor size, lymph node involvement) may be explored but will be considered hypothesis-generating only.","At 12 months",{"measure":23,"description":24,"timeFrame":25},"Prevalence of occult contralateral disease","Among patients who undergo completion thyroidectomy and\u002For contralateral neck dissection, will assess the prevalence of previously undetected foci of medullary thyroid cancer in the contralateral thyroid lobe and contralateral cervical lymph nodes. Pathologic findings will be reported as proportions with corresponding exact 95% confidence intervals.","Perioperative\u002FPeriprocedural",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","PRIMARY OBJECTIVE:\n\nI. To determine the number of patients that have no biochemical evidence of persistent medullary thyroid cancer following thyroid lobectomy and ipsilateral prophylactic central neck dissection alone versus number of patients with biochemical evidence of persistent MTC that requires completion thyroidectomy.\n\nSECONDARY OBJECTIVES:\n\nI. Determine the short-term oncologic treatment outcomes of a novel staged approach to sporadic medullary thyroid cancer, defined by response to therapy category (excellent, biochemical incomplete, structural incomplete).\n\nII. Determine the prevalence of undetected foci of medullary thyroid cancer in contralateral thyroid lobe and contralateral lymph nodes.\n\nOUTLINE:\n\nPatients undergo thyroid lobectomy with unilateral central neck dissection on study. Patients then undergo blood sample collection for calcitonin and carcinoembryonic antigen (CEA) monitoring with neck ultrasound and\u002For gallium-68 (Ga-68) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET)\u002Fcomputed tomography (CT) at 3 and 6 month follow-ups. Patients with no biochemical or imaging evidence of persistent disease undergo routine cancer surveillance. Patients with either of the following: 1) Elevated or rising calcitonin and\u002For CEA plus imaging suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes, or 2) Elevated or rising calcitonin and\u002For CEA with negative imaging for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe, may undergo completion thyroidectomy and\u002For contralateral neck dissection during follow up. Patients also undergo additional blood sample collection, neck ultrasound, and\u002For Ga-68 or FDG PET\u002FCT throughout the study.\n\nAfter completion of study intervention, patients are followed up at day 14 and months 3, 6, 12, 18, and 24.",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"Treatment (thyroid lobectomy, unilateral neck dissection)","EXPERIMENTAL","Patients undergo thyroid lobectomy with unilateral central neck dissection on study. Patients then undergo blood sample collection for calcitonin and CEA monitoring with neck ultrasound and\u002For Ga-68 or FDG PET\u002FCT at 3 and 6 month follow-ups. Patients with no biochemical or imaging evidence of persistent disease undergo routine cancer surveillance. Patients with either of the following: 1) Elevated or rising calcitonin and\u002For CEA plus imaging suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes, or 2) Elevated or rising calcitonin and\u002For CEA with negative imaging for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe, may undergo completion thyroidectomy and\u002For contralateral neck dissection during follow up. Patients also undergo additional blood sample collection, neck ultrasound, and\u002For Ga-68 or FDG PET\u002FCT throughout the study.",[40,41,42,43,44,45,46,47],"Procedure: Biospecimen Collection","Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan","Procedure: Ga-68 PET\u002FCT Scan","Procedure: Neck Dissection","Behavioral: Surveillance","Procedure: Thyroid Lobectomy","Procedure: Thyroidectomy","Procedure: Ultrasound Imaging",[49,59,65,72,76,79,86,93,97],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[36],[55,56,57,58],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":50,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"FDG-Positron Emission Tomography and Computed Tomography Scan","Undergo FDG PET\u002FCT",[36],[64],"FDG PET\u002FCT",{"type":50,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"Ga-68 PET\u002FCT Scan","Undergo Ga-68 PET\u002FCT",[36],[70,71],"Gallium-68 PET\u002FCT Scan","Gallium-68 Positron Emission Tomography and Computed Tomography Scan",{"type":50,"name":73,"description":74,"armGroupLabels":75,"otherNames":26},"Neck Dissection","Undergo unilateral central neck dissection",[36],{"type":50,"name":73,"description":77,"armGroupLabels":78,"otherNames":26},"Undergo contralateral neck dissection",[36],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"BEHAVIORAL","Surveillance","Undergo routine cancer surveillance",[36],[85],"Epidemiology \u002F Surveillance",{"type":50,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"Thyroid Lobectomy","Undergo thyroid lobectomy",[36],[91,92],"Lobectomy of Thyroid Gland","Unilateral Thyroid Lobectomy",{"type":50,"name":94,"description":95,"armGroupLabels":96,"otherNames":26},"Thyroidectomy","Undergo completion thyroidectomy",[36],{"type":50,"name":98,"description":99,"armGroupLabels":100,"otherNames":101},"Ultrasound Imaging","Undergo neck ultrasound",[36],[102,103,104,105,106,107,108,109],"2-Dimensional Grayscale Ultrasound Imaging","2-Dimensional Ultrasound Imaging","2D-US","Ultrasonography","Ultrasound","Ultrasound Test","Ultrasound, Medical","US",[111],{"name":112,"affiliation":113,"role":114},"James Wu, MD","UCLA \u002F Jonsson Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[116],{"name":117,"role":118,"phone":119,"phoneExt":26,"email":120},"Elena Hughes","CONTACT","310 206-9145","EGHughes@mednet.ucla.edu",[122],{"facility":113,"status":26,"city":123,"state":124,"zip":125,"country":126,"countryCode":109,"cosmosGeoPoint":127,"geoPoint":132,"contacts":133},"Los Angeles","California","90095","United States",{"type":128,"coordinates":129},"Point",[130,131],-118.24368,34.05223,{"lat":131,"lon":130},[134,137],{"name":117,"role":118,"phone":135,"phoneExt":26,"email":136},"310-206-9145","eghughes@mednet.ucla.edu",{"name":112,"role":114,"phone":26,"phoneExt":26,"email":26},{"type":139,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[141],{"name":142,"class":143},"Eli Lilly and Company","INDUSTRY","100640816",false,"NCT07612293","STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection","STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection for the Treatment of Sporadic Medullary Thyroid Cancer, STAGE-MTC Trial","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age at time of diagnosis\n* Documentation of a medullary thyroid cancer diagnosis as evidenced by:\n\n  * Thyroid fine needle aspiration biopsy with cytologist consistent with medullary thyroid cancer\n  * Indeterminate cytology from thyroid fine needle aspiration with elevated serum calcitonin OR thyroid molecular testing consistent with medullary thyroid cancer\n* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study\n* Appropriate candidate for thyroid lobectomy and\u002For total thyroidectomy\n\nExclusion Criteria:\n\n* Indication for total thyroidectomy unrelated to medullary thyroid cancer:\n\n  * Graves' disease\n  * Symptomatic multinodular goiter\n  * Contralateral symptomatic benign nodules\n* Ultrasound findings consistent with:\n\n  * Cervical lymphadenopathy involving lateral neck or contralateral central neck\n  * Suspicious thyroid nodules \\> 1 cm that are Thyroid Imaging Reporting and Data Systems 2 (TIRADS2) or higher without fine needle aspiration (FNA)\n\n    * Pure cystic and spongiform nodules do not require FNA\n    * Patients with nodules that meet criteria above can elect to undergo FNA, and may enroll in study if benign cytology is noted\n* Identification of germline RET mutation on preoperative genetic testing","ALL","18 Years",{"count":153,"type":154},100,"ESTIMATED","INTERVENTIONAL",[28],"This clinical trial studies how well thyroid lobectomy with ipsilateral central neck dissection works to treat medullary thyroid cancer (MTC) in patients without a germline RET mutation (sporadic). Currently, sporadic and germline RET (rearranged during transfection) mutation positive MTCs that are limited to the thyroid are managed in the same way, complete surgical removal of the entire thyroid gland (total thyroidectomy) with surgical removal of lymph nodes and other tissues on both sides of the neck (bilateral central neck dissection). Total thyroidectomy and bilateral central neck dissection carry a high risk of complications, and total thyroidectomy requires patients to take lifelong thyroid hormone replacement therapy, which can impact quality of life. Research has shown that patients with sporadic MTC do not have a high risk of developing MTC in the remaining normal thyroid tissue and that they may be able to be managed differently than patients with germline RET mutations. Thyroid lobectomy with ipsilateral central neck dissection is a surgical procedure which removes only the lobe of the thyroid gland that is affected by cancer as well as the lymph nodes and other tissues from the affected side of the neck. Thyroid lobectomy with ipsilateral central neck dissection may be a safer, more tolerable, and\u002For more effective way to treat sporadic MTC.",[159],"Thyroid Gland Medullary Carcinoma","NOT_YET_RECRUITING","2026-05-27",{"date":163,"type":164},"2026-05-28","ACTUAL",{"date":166,"type":154},"2026-09-02",{"date":168,"type":154},"2032-04-21",{"name":5,"class":6},1]