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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    524
  • sponsor
    Jinsong Hou
Updated on 7 October 2022
metastasis

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.

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.

Details
Condition Carcinoma, Squamous Cell
Treatment Resection for primary lesion and cervical lymph node dissection, Resection for primary lesion, Resection for primary lesion only
Clinical Study IdentifierNCT02743832
SponsorJinsong Hou
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Do not meet the inclusion criteria
The primary lesion is more than 4cm or invade adjacent tissues
Do not review on schedule
Patients receive not only surgical procedures, but other antineoplastic treatment
There are serious adverse events after operation
Patients quit the study voluntarily
Patients quit the study because of physical condition
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