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

December 11, 2023 updated by: Mohamed Shawky, Cairo University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry, Cairo University
        • Contact:
          • Mohamed Shawky, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional 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
Intervention group
Procedure: removal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor thickness in mellimeters
Time Frame: one week: specimens are submitted immediately after surgery
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
Time Frame: One week : submitted immediately after surgery
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
Time Frame: 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
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohamed Shawky, MSc, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 3, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cairo uni PhD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

will be available upon reasonable request

IPD Sharing Time Frame

After study completion

IPD Sharing Access Criteria

From Corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tongue Neoplasms

Clinical Trials on removal of primary tumor, neck dissection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe