NCT02743832

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
524

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jun 2027

First Submitted

Initial submission to the registry

April 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
10 years until next milestone

Study Start

First participant enrolled

May 4, 2026

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

26 days

First QC Date

April 15, 2016

Last Update Submit

April 24, 2026

Conditions

Carcinoma, Squamous Cell

Keywords

Oral squamous cell carcinomaTumor buddingCervical lymph node dissection

Outcome Measures

Primary Outcomes (2)

  • Five-year survival rate

    The time from the first operation to death was recorded

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

  • Disease free survival

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

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

Secondary Outcomes (2)

  • Recurrence rate

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

  • Evaluation of quality of life

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

Study Arms (4)

High-level tumor budding group with CLND

EXPERIMENTAL

Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.

Procedure: Resection for primary lesion and cervical lymph node dissection

High-level tumor budding group without CLND

EXPERIMENTAL

Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.

Procedure: Resection for primary lesion only

Low-level tumor budding group with CLND

EXPERIMENTAL

Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.

Procedure: Resection for primary lesion and cervical lymph node dissection

Low-level tumor budding group without CLND

EXPERIMENTAL

Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.

Procedure: Resection for primary lesion only

Interventions

Resection for primary lesion and cervical lymph node dissectionPROCEDURE

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

High-level tumor budding group with CLNDLow-level tumor budding group with CLND
Resection for primary lesion onlyPROCEDURE

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

High-level tumor budding group without CLNDLow-level tumor budding group without CLND

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510055, China

RECRUITING

Related Publications (5)

  • Almangush A, Salo T, Hagstrom J, Leivo I. Tumour budding in head and neck squamous cell carcinoma - a systematic review. Histopathology. 2014 Nov;65(5):587-94. doi: 10.1111/his.12471. Epub 2014 Oct 6.

    PMID: 24897954RESULT

  • Almangush A, Bello IO, Keski-Santti H, Makinen LK, Kauppila JH, Pukkila M, Hagstrom J, Laranne J, Tommola S, Nieminen O, Soini Y, Kosma VM, Koivunen P, Grenman R, Leivo I, Salo T. Depth of invasion, tumor budding, and worst pattern of invasion: prognostic indicators in early-stage oral tongue cancer. Head Neck. 2014 Jun;36(6):811-8. doi: 10.1002/hed.23380. Epub 2013 Sep 2.

    PMID: 23696499RESULT

  • Da Sacco L, Masotti A. Recent insights and novel bioinformatics tools to understand the role of microRNAs binding to 5' untranslated region. Int J Mol Sci. 2012 Dec 27;14(1):480-95. doi: 10.3390/ijms14010480.

    PMID: 23271365RESULT

  • Xie N, Wang C, Liu X, Li R, Hou J, Chen X, Huang H. Tumor budding correlates with occult cervical lymph node metastasis and poor prognosis in clinical early-stage tongue squamous cell carcinoma. J Oral Pathol Med. 2015 Apr;44(4):266-72. doi: 10.1111/jop.12242. Epub 2014 Aug 28.

    PMID: 25169851RESULT

  • Hori Y, Kubota A, Yokose T, Furukawa M, Matsushita T, Takita M, Mitsunaga S, Mizoguchi N, Nonaka T, Nakayama Y, Oridate N. Predictive Significance of Tumor Depth and Budding for Late Lymph Node Metastases in Patients with Clinical N0 Early Oral Tongue Carcinoma. Head Neck Pathol. 2017 Dec;11(4):477-486. doi: 10.1007/s12105-017-0814-1. Epub 2017 Apr 3.

    PMID: 28374102RESULT

MeSH Terms

Conditions

Carcinoma, Squamous CellSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Jinsong Hou, PhD

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

    STUDY DIRECTOR

Central Study Contacts

Jinsong Hou, PhD

CONTACT

86-13825141651houjsgz@aliyun.com

Cheng Wang, PhD

CONTACT

86-13760853366drwangcheng@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Director

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 19, 2016

Study Start

May 4, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)