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

Carcinoma, Squamous Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02743832
• Other study ID #: HouJ-2015018
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2022
• Source: Sun Yat-sen University
• Contact: Jinsong Hou, PhD
• Phone: 86-13825141651
• Email: houjsgz[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 524
• Est. completion date: June 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck

Intervention

Procedure:
• 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.
• Resection for primary lesion only
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.

Locations

Country	Name	City	State
China	Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Jinsong Hou	First Affiliated Hospital, Sun Yat-Sen University, Hospital of Stomatology, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (5)

Almangush A, Bello IO, Keski-Säntti H, Mäkinen LK, Kauppila JH, Pukkila M, Hagström J, Laranne J, Tommola S, Nieminen O, Soini Y, Kosma VM, Koivunen P, Grénman R, Leivo I, Salo T. Depth of invasion, tumor budding, and worst pattern of invasion: prognostic — View Citation

Almangush A, Salo T, Hagström 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. Review. — View Citation

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. Review. — View Citation

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 Car — View Citation

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.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Recurrence rate	To investigate the local recurrence rate and the recurrence rate of cervical lymphatic metastasis.	After the first year, review every three months at a time;The next four years, review every six months at a time.
Secondary	Evaluation of quality of life	Complete the University of Washington Quality of Life Form (UW-QOL) To understand the quality of life of patients after surgery.	After the first year, review every three months at a time;The next four years, review every six months at a time.