RecruitingNot ApplicableNCT02743832

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.


Sponsor

Jinsong Hou

Enrollment

524 participants

Start Date

May 4, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 YearsMax Age: 70 Years

Inclusion Criteria13

  • 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.
  • 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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Interventions

PROCEDUREResection 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.

PROCEDUREResection for primary lesion only

Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.


Locations(1)

Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT02743832


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