Assessment of the Effect of Tumor Thickness and Site on Level IV Cervical Lymph Nodes in Squamous Cell Carcinoma of the Tongue and Floor of the Mouth: A Case Series Study

Study Overview
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Brief Summary
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Regarding oral cavity cancer, the high incidence of neck metastasis along with its impact on survival and prognosis are in favor of elective neck dissection. Moreover, occult metastases could develop at lower levels in the neck (levels IV-V) Regarding the tongue, the rate of skip (occult) metastasis involving unremoved level IV cervical lymph nodes in squamous cell carcinoma of the tongue ranges from 0 % - 11.4 %. However, no data is available or a correlation between the risk of level IV involvement and the affection of specific tongue subsites or a certain cutoff value of tumor thickness.

Official Title
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Assessment of the Effect of Tumor Thickness and Site on Level IV Cervical Lymph Nodes in Squamous Cell Carcinoma of the Tongue and Floor of the Mouth: A Case Series Study

Conditions
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Tongue Neoplasms

Intervention / Treatment
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* Procedure: removal of primary tumor, neck dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with squamous cell carcinoma of the tongue and floor of the mouth. Age group: from 15 to 60 years old No sex predilection Exclusion Criteria: Patients with recurrent squamous cell carcinoma of the tongue and floor of the mouth. Irradiated patients or those taking chemotherapy.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with squamous cell carcinoma of the tongue and floor of the mouth<br>Intervention group | Procedure: removal of primary tumor, neck dissection<br>* removal of the primary tumor with safety margins and removal of the neck lymph node levels I, II, III and IV. histological assessment of tumor thickness and whether it is associated with positive nodes in level IV or not.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor thickness in mellimeters | histological assessment of tumor thickness of the resected tumor and assessment of level IV lymph nodes | one week: specimens are submitted immediately after surgery | 
| Number of affected level IV cervical lymph nodes | In each case the specimen will be assessed for level IV lymph nodes affection | One week : submitted immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| affected tongue site in relation to level IV cervical lymph nodes | histological assessment of level IV lymph nodes to determine if it is affected with tumor site on the tongue (lateral border, dorsum, ventral ....) which will be documented before surgery during examination | One week |