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

Not Applicable

Recruiting

• Conditions: Tongue Neoplasms
• Interventions: Procedure: removal of primary tumor, neck dissection

• Registration Number: NCT06169605
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-13
• Study Start: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-26
• Last Update Posted: 2024-05-29
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• Patients with recurrent squamous cell carcinoma of the tongue and floor of the mouth.
• Irradiated patients or those taking chemotherapy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with squamous cell carcinoma of the tongue and floor of the mouth	removal of primary tumor, neck dissection	Intervention group

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
affected tongue site in relation to level IV cervical lymph nodes	One week	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

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt