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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06169605

Enrollment

Registered

2023-12-13

Start date

2024-04-01

Completion date

2025-05-30

Last updated

2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tongue Neoplasms

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.

Interventions

PROCEDUREremoval of primary tumor, neck dissection

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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

Secondary

Measure	Time frame	Description
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

Countries

Egypt

Contacts

Primary ContactMohamed Shawky, MSc

m.shawky1993@gmail.com+201223933897

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026