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

NCT ID: NCT02743832

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 524 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-04
• Study Completion Date: 2025-06-30

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.

Detailed Description

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.

Conditions

Carcinoma, Squamous Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High-level tumor budding group with CLND

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.

Group Type: EXPERIMENTAL

Resection for primary lesion and cervical lymph node dissection

Intervention Type: PROCEDURE

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

High-level tumor budding group without CLND

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

Group Type: EXPERIMENTAL

Resection for primary lesion only

Intervention Type: PROCEDURE

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

Low-level tumor budding group with CLND

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.

Group Type: EXPERIMENTAL

Resection for primary lesion and cervical lymph node dissection

Intervention Type: PROCEDURE

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

Low-level tumor budding group without CLND

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

Group Type: EXPERIMENTAL

Resection for primary lesion only

Intervention Type: PROCEDURE

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

Interventions

Resection 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.

Intervention Type: PROCEDURE

Resection for primary lesion only

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

Intervention Type: PROCEDURE

Eligibility 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.

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Hospital of Stomatology, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Jinsong Hou

OTHER

Sponsor Role: lead

Responsible Party

Jinsong Hou

Vice Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jinsong Hou, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinsong Hou, PhD

Role: CONTACT

houjsgz@aliyun.com

86-13825141651

Cheng Wang, PhD

Role: CONTACT

drwangcheng@outlook.com

86-13760853366

Facility Contacts

Jinsong Hou, PhD

Role: primary

houjsgz@aliyun.com

86-13825141651

Cheng Wang, PhD

Role: backup

drwangcheng@outlook.com

86-13760853366

References

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.

Reference Type: RESULT

PMID: 24897954 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23696499 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23271365 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25169851 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28374102 (View on PubMed)

Other Identifiers

HouJ-2015018

Identifier Type: -

Identifier Source: org_study_id