[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100421381":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":91,"collaborators":25,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":25,"enrollmentInfo":103,"targetDuration":25,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Centre Francois Baclesse","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm","EXPERIMENTAL","Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)",[13],"Procedure: bilateral mucosectomy + tonsillectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","ACTIVE_COMPARATOR","Tonsillectomy alone (unilateral or bilateral at the choice of the investigator)",[19],"Procedure: tonsillectomy",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"PROCEDURE","bilateral mucosectomy + tonsillectomy",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"tonsillectomy","tonsillectomy (unilateral or bilateral at the choice of the investigator)",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Vianney BASTIT, MD","CONTACT","33231455050","v.bastit@baclesse.unicancer.fr",[37,53,61,72,80],{"facility":38,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Centre François Baclesse","RECRUITING","Caen","France","FR",{"type":44,"coordinates":45},"Point",[46,47],-0.35912,49.18585,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":25,"phoneExt":25,"email":52},"LASNE CARDON Audrey, MD","a.lasne-cardon@baclesse.unicancer.fr",{"facility":54,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"CHU CAEN",{"type":44,"coordinates":56},[46,47],{"lat":47,"lon":46},[59],{"name":60,"role":33,"phone":25,"phoneExt":25,"email":25},"Maxime HUMBERT, MD",{"facility":62,"status":39,"city":63,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Centre Oscar Lambret","Lille",{"type":44,"coordinates":65},[66,67],3.05512,50.63391,{"lat":67,"lon":66},[70],{"name":71,"role":33,"phone":25,"phoneExt":25,"email":25},"Samia BOUHIR, MD",{"facility":73,"status":39,"city":63,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"Chru Lille",{"type":44,"coordinates":75},[66,67],{"lat":67,"lon":66},[78],{"name":79,"role":33,"phone":25,"phoneExt":25,"email":25},"Francois Mouawad, MD",{"facility":81,"status":39,"city":82,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"CHU Rouen","Rouen",{"type":44,"coordinates":84},[85,86],1.09932,49.44313,{"lat":86,"lon":85},[89],{"name":90,"role":33,"phone":25,"phoneExt":25,"email":25},"Sophie DENEUVE, MD",{"type":92,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100421381","phase-2-interest-of-bilateral-basic-tongue-mucosectomy-assisted-by-robot-or-laser-in-combination-with-tonsillectomy-in-the-assessment-of-prevalent-cervical-lymphadenopathy-100421381",false,"NCT04767048","Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy","Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study","RoboCUP","Inclusion Criteria:\n\n* Patient with a prevalent head and neck lymphadenopathy with positive or non-contributory fine needle aspiration, or having had an adenectomy revealing a metastasis of squamous cell carcinoma, a PET examination, an injected cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor\n* Performance Status \\\u003C 2\n* Patient aged 18 or over\n* Patient affiliated with social security system\n* Informed consent signed\n\nExclusion Criteria:\n\n* History of squamous cell carcinoma of the VADS or skin of the face.\n* History of cervico-facial radiotherapy\n* Primary tumor discovering during pan-endoscopy\n* Inexposable patient lead not to possible mucosectomy\n* Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic bilateral mucosectomy of language)\n* Distant metastases\n* Lymphadenopathy inoperable\n* Patient with a contraindication to radiotherapy\n* Pregnant or breastfeeding woman\n* Women of childbearing potential without effective contraception\n* Patient under guardianship or unable to give informed consent\n* Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons","ALL","18 Years",{"count":104,"type":105},72,"ESTIMATED","INTERVENTIONAL",[108],"PHASE2","We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy",[111,112],"Cancer of Head and Neck","Adenopathy",[114,115],"mucosectomy","tonsil","2024-10-10",{"date":118,"type":119},"2024-10-15","ACTUAL",{"date":121,"type":119},"2021-06-30",{"date":123,"type":105},"2029-03",{"name":5,"class":6},5]