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A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
Study Purpose
The purpose of this study is to determine whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria:
1. Han race; 2. Oral squamous cell carcinoma is confirmed by pathology; 3. The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa; 4. The primary lesion is no more than 4cm; 5. Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI; 6. Patients and families agree to participate in the study; 7. Patients do not have cognitive disorders.Exclusion Criteria:
1. Do not meet the inclusion criteria; 2. The primary lesion is more than 4cm or invade adjacent tissues; 3. Do not review on schedule; 4. Patients receive not only surgical procedures, but other antineoplastic treatment; 5. There are serious adverse events after operation; 6. Patients quit the study voluntarily; 7. Patients quit the study because of physical condition.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The disease, disorder, syndrome, illness, or injury that is being studied.
Oral squamous cell carcinoma is the most common malignant tumor of oral and maxillofacial region, and prone to early cervical lymph node metastases. Lymphatic spread is associated with increased risk of loco-regional recurrence, therefore, the identification of lymph node metastases preoperatively is very important for the optimal surgical therapy. Recently, cervical lymph node dissection(CLND) is performed in the presence of oral squamous cell carcinoma. However, whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma is still controversial. CLND will represent over-treatment in some case of early-stage oral squamous cell carcinoma. Therefore, How to accurately predict whether a patient should be performed CLND is important. Our previous study show that tumor budding is closely related to lymphatic spread in the oral squamous cell carcinoma. The purpose of this study is to find that whether the tumor budding guide the individualized surgical planning of early-stage oral squamous cell carcinoma.
Arms
Experimental: High-level tumor budding group with CLND
Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
Experimental: High-level tumor budding group without CLND
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
Experimental: Low-level tumor budding group with CLND
Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
Experimental: Low-level tumor budding group without CLND
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
Interventions
Procedure: - Resection for primary lesion and cervical lymph node dissection
Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.
Procedure: - Resection for primary lesion only
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University
Guangzhou, Guangdong, 510055
Site Contact
Jinsong Hou, PhD
[email protected]
86-13825141651
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