[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563984":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":105,"collaborators":25,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":25,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":25,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Huashan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","PLACEBO_COMPARATOR","The patients in the experimental arm will receive radical resection of the primary lesion only, with neck observation, the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion. Ultrasonography, CT scan, and\u002For MRI examination will be used to detect lesions.",[13],"Procedure: Neck management",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","ACTIVE_COMPARATOR","The patients in the control arm will receive radical resection of the primary lesion with the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion, they will also receive simultaneous elective neck dissection. Ultrasonography, CT scan, and\u002For MRI examination will be used to detect lesions.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Neck management","In the experimental arm: the neck management is neck observation, simultaneous elective neck dissection is not performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and\u002For MRI will be used to detect lesions.\n\nIn the control arm: the neck management is elective neck dissection. Simultaneous elective neck dissection is performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and\u002For MRI will be used to detect lesions.",[15,9],null,[27],{"name":28,"affiliation":5,"role":29},"Lai-ping Zhong, MD, PhD","PRINCIPAL_INVESTIGATOR",[31,35],{"name":28,"role":32,"phone":33,"phoneExt":25,"email":34},"CONTACT","+862152888915","zhonglp@hotmail.com",{"name":36,"role":32,"phone":37,"phoneExt":38,"email":39},"Liang Gu, MD","+862152889999","7182","guliang@hotmail.com",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Huashan Hospital, Fudan University","RECRUITING","Shanghai","200040","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55,56,58,60,62,64,66,68,70,72,74,75,77,79,81,83,85,87,89,91,93,95,97,99,101,103],{"name":28,"role":32,"phone":33,"phoneExt":25,"email":34},{"name":36,"role":32,"phone":37,"phoneExt":38,"email":57},"kqyxyhyy@163.com",{"name":59,"role":32,"phone":25,"phoneExt":25,"email":25},"Jing-song Li, MD, PhD",{"name":61,"role":32,"phone":25,"phoneExt":25,"email":25},"Xue-kui Liu, MD, PhD",{"name":63,"role":32,"phone":25,"phoneExt":25,"email":25},"Lei Tao, MD, PhD",{"name":65,"role":32,"phone":25,"phoneExt":25,"email":25},"Yu Wang, MD, PhD",{"name":67,"role":32,"phone":25,"phoneExt":25,"email":25},"Can-hua Jiang, MD, PhD",{"name":69,"role":32,"phone":25,"phoneExt":25,"email":25},"Li-song Lin, MD, PhD",{"name":71,"role":32,"phone":25,"phoneExt":25,"email":25},"Jian Meng, MD, PhD",{"name":73,"role":32,"phone":25,"phoneExt":25,"email":25},"Wen-bo Yang, MD",{"name":36,"role":32,"phone":25,"phoneExt":25,"email":25},{"name":76,"role":32,"phone":25,"phoneExt":25,"email":25},"Hui-yong Zhu, MD, PhD",{"name":78,"role":32,"phone":25,"phoneExt":25,"email":25},"Yan-ming Liu, MD, PhD",{"name":80,"role":32,"phone":25,"phoneExt":25,"email":25},"Chao Chen, MD, PhD",{"name":82,"role":32,"phone":25,"phoneExt":25,"email":25},"Lei Xie, MD, PhD",{"name":84,"role":32,"phone":25,"phoneExt":25,"email":25},"Fa-yu Liu, MD, PhD",{"name":86,"role":32,"phone":25,"phoneExt":25,"email":25},"Chuan-yu Hu, MD, PhD",{"name":88,"role":32,"phone":25,"phoneExt":25,"email":25},"Jian-bo Xu, MD",{"name":90,"role":32,"phone":25,"phoneExt":25,"email":25},"Can Xiao, MD, PhD",{"name":92,"role":32,"phone":25,"phoneExt":25,"email":25},"Tian-shu Xu, MD",{"name":94,"role":32,"phone":25,"phoneExt":25,"email":25},"Kai Yin, MD",{"name":96,"role":32,"phone":25,"phoneExt":25,"email":25},"Yong-hong Zhang, MD",{"name":98,"role":32,"phone":25,"phoneExt":25,"email":25},"Yu-lin Jia, MD, PhD",{"name":100,"role":32,"phone":25,"phoneExt":25,"email":25},"Wei-jie Dong, MD",{"name":102,"role":32,"phone":25,"phoneExt":25,"email":25},"Zhi-en Feng, MD, PhD",{"name":104,"role":32,"phone":25,"phoneExt":25,"email":25},"Cheng-zhe Yang, MD, PhD",{"type":29,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Lai-ping Zhong","Professor","100563984","neck-observation-or-elective-neck-dissection-in-ct1n0m0-oscc-100563984",false,"NCT06623266","Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC","Neck Observation Versus Selective Neck Dissection in Patients with CT1N0M0 Oral Squamous Cell Carcinoma: a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Tumor site: tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar eara\n* Clinical stage is cT1N0M0 (AJCC 8th edition)\n* Pathological diagnosis of squamous cell carcinoma\n* Sign the informed consent form\n\nExclusion Criteria:\n\n* More than 2 lesions found in the oral cavity\n* Known history of malignant tumor within five years (unless the patient has undergone curative treatment and there is no disease recurrence within 5 years since the start of treatment)\n* History of unilateral or bilateral neck dissection in the past\n* History of previous head and neck radiotherapy\n* Pregnant or lactating women\n* Severe, uncontrolled infection or known HIV infection; or previous organ transplantation, stem cell or bone marrow transplantation\n* Participated in other clinical studies within 30 days before enrollment\n* Other circumstances that the researcher considers unsuitable for participation in the study","ALL","18 Years","75 Years",{"count":119,"type":120},300,"ESTIMATED","INTERVENTIONAL",[123],"NA","To evaluate the clinical outcomes of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life in the patients with cT1N0M0 oral squamous cell carcinoma, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only.",[126,127],"Oral Cancer","Lymph Node Metastasis",[129,130,131,132,133],"Oral squamous cell carcinoma","Early stage","Neck dissection","Neck observation","Lymph node metastasis rate","2024-11-12",{"date":136,"type":137},"2024-11-14","ACTUAL",{"date":139,"type":137},"2024-09-26",{"date":141,"type":120},"2028-09-30",{"name":5,"class":6},1]