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Neck Observation or Elective Neck Dissection in cT1N0M0 OSCC

RecruitingNAAges 18 Years - 75 YearsAllHuashan Hospital
NCT06623266 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Tumor site: tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar eara * Clinical stage is cT1N0M0 (AJCC 8th edition) * Pathological diagnosis of squamous cell carcinoma * Sign the informed consent form Exclusion Criteria: * More than 2 lesions found in the oral cavity * 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) * History of unilateral or bilateral neck dissection in the past * History of previous head and neck radiotherapy * Pregnant or lactating women * Severe, uncontrolled infection or known HIV infection; or previous organ transplantation, stem cell or bone marrow transplantation * Participated in other clinical studies within 30 days before enrollment * Other circumstances that the researcher considers unsuitable for participation in the study
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What it tests

  • Neck management
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Where

1 site
Huashan Hospital, Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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