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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Second Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Hospital of Stomatology, Sun Yat-Sen University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Evaluation of quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinsong Hou, PhD | Contact | 86-13825141651 | houjsgz@aliyun.com | |
| Cheng Wang, PhD | Contact | 86-13760853366 | drwangcheng@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinsong Hou, PhD | Guanghua School of Stomatology, Hospital of Stomatolagy Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510055 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24897954 | Result | 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. | |
| 23696499 | Result | 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. |
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| Resection for primary lesion only | Procedure | Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma. |
|
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. |
| 23271365 | Result | 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. |
| 25169851 | Result | 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. |
| 28374102 | Result | 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. |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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