NCT02743832

A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.

A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 524 (estimated)
• Sponsor: Jinsong Hou · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Carcinoma, Squamous Cell

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-04
• Primary completion: 2025-05-30
• Completion: 2025-06-30
• First posted: 2016-04-19
• Last updated: 2022-09-07

Locations

1 site across 1 country: China