Guiding surgery for early-stage oral squamous cell carcinoma using tumor budding.
A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
This study is testing whether checking for tumor budding can help doctors decide if patients with early-stage oral cancer need to have their lymph nodes removed during surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 524 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT02743832 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are Han race individuals diagnosed with early-stage oral squamous cell carcinoma without cervical lymph node or distant metastases.
Not a fit: Patients with larger tumors, those with metastases, or those undergoing other antineoplastic treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more tailored surgical interventions, reducing unnecessary procedures and improving patient outcomes.
How similar studies have performed: Previous studies have indicated a correlation between tumor budding and lymphatic spread, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.