A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:
• Han race;
• Oral squamous cell carcinoma is confirmed by pathology;
• The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa;
• The primary lesion is no more than 4cm;
• Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI;
• Patients and families agree to participate in the study;
• Patients do not have cognitive disorders.
Locations
Other Locations
China
Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Jinsong Hou, PhD
houjsgz@aliyun.com
86-13825141651
Backup
Cheng Wang, PhD
drwangcheng@outlook.com
86-13760853366
Time Frame
Start Date: 2022-09-04
Completion Date: 2025-06-30
Participants
Target number of participants: 524
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital of Stomatology, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University
Leads: Jinsong Hou