Guiding surgery for early-stage oral squamous cell carcinoma using tumor budding.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine the necessity of cervical lymph node dissection in patients with early-stage oral squamous cell carcinoma by evaluating the presence of tumor budding. The research focuses on identifying lymph node metastases preoperatively to optimize surgical therapy and reduce the risk of over-treatment. By analyzing the relationship between tumor budding and lymphatic spread, the study seeks to develop individualized surgical planning for affected patients. Participants will undergo either resection for the primary lesion with or without cervical lymph node dissection based on their tumor budding status.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Jinsong Hou, PhD
• Email: houjsgz@aliyun.com
• Phone: 86-13825141651

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.