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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02743832
Other study ID # HouJ-2015018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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