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NCT Number: NCT02743832

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

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.

Recruiting

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resection for primary lesion and cervical lymph node dissection

Procedure

Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.

Resection for primary lesion only

Procedure

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

Primary outcomes

  1. Five-year survival rate

    Time frame: After the first year, review every three months at a time;The next four years, review every six months at a time.

    The time from the first operation to death was recorded

  2. Disease free survival

    Time frame: After the first year, review every three months at a time;The next four years, review every six months at a time.

    The time from the start of surgery to the discovery of the first cervical lymphatic metastases

Secondary outcomes

  1. Recurrence rate

    Time frame: After the first year, review every three months at a time;The next four years, review every six months at a time.

    To investigate the local recurrence rate and the recurrence rate of cervical lymphatic metastasis.

  2. Evaluation of quality of life

    Time frame: After the first year, review every three months at a time;The next four years, review every six months at a time.

    Complete the University of Washington Quality of Life Form (UW-QOL) To understand the quality of life of patients after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng Wang, PhD

CONTACT

[email protected]

86-13760853366

Jinsong Hou, PhD

CONTACT

[email protected]

86-13825141651

Sponsors and collaborators

Lead sponsor

Jinsong Hou

Other

Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University
  • Hospital of Stomatology, Sun Yat-Sen University
  • Second Affiliated Hospital, Sun Yat-Sen University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 19, 2016
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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