Primary Tumor Depth of Invasion and Lymph Node Management in Oral Squamous Cell Carcinoma

NCT07127614 | Not Yet Recruiting

• 1 other identifier: 1008/2042
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the diagnostic accuracy of preoperative MRI in the determination of the primary tumor depth of invasion (DOI) as a predictor factor in neck lymph nodes management in T1T2N0 oral cavity squamous cell carcinomas as compared to the pathological depth of invasion

Conditions

Squamous Cell Carcinoma Mouth

Keywords

squamous cell carcinoma; MRI; diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  determination of the diagnostic accuracy of MRI in determining the depth of invasion compared to the pathological depth of invasion

  immediately after the surgery

Study Arms (1)

study group

Patients with biopsy proven oral squamous cell carcinoma with the edition T1or T2 N0 based on TNM staging by American Joint cancer center AJCC 8th edition

Diagnostic Test: MRI; Diagnostic Test: Histo-Pathological examination of the resected tumor tissues

Interventions

MRI DIAGNOSTIC_TEST

pre-operative MRI scan

Also known as: index test

study group

Histo-Pathological examination of the resected tumor tissues DIAGNOSTIC_TEST

histo-pathological examination of the resected tumor tissues with the lymph nodes involved to determine the pathological depth of invasion

Also known as: Reference test

study group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with biopsy-proven oral squamous cell carcinoma with the edition T1or T2 N0 based on TNM staging by the American Joint Cancer Center

You may qualify if:

• Patients with biopsy-proven oral squamous cell carcinoma with the edition T1or T2 N0 based on TNM staging by the American Joint Cancer Center AJCC 8th edition
• The primary tumor has a depth of invasion (DOI) greater than 4 mm
• Clinical N0 status confirmed by reasonable parameters includes computed tomography CT, MRI, -Ultrasonography,( US fine needle aspiration in suspected lymph nodes )
• The primary tumor must be reliably resected to a clear margin without the need for entry of the neck for reconstruction

You may not qualify if:

• Patients with T3T4 OCSCC
• Proven or suspected positive neck node
• Patient with distant metastasis
• Patient with gross injury to the neck that precludes proper surgical dissection.
• Patient with a history of radiotherapy to the neck
• Recurrent cases of OCSCC or recurrent node disease
• Patient with previous neck node biopsy or previous neck dissection
• Patient with a medical condition or performance that interferes with the surgical intervention as judged by the specialist physician

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

AL Sayed Galal Hospital Al-Azhar University

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy from the tumor will be retained as fixed tissues to undergo the histopathological examination and determination of the pathological depth of invasion

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Study Officials

• Wael A ElMohandes, PhD

  oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar University

  STUDY DIRECTOR

• Ahmed M Alfar, PhD

  oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar University

  STUDY CHAIR

• Mohamed A Mohamed, PhD

  oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar University

  STUDY CHAIR

• Mohamed AW Amin, PhD

  oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar University

  STUDY CHAIR

Central Study Contacts

Islam M Ali, MSc

CONTACT

+201274454102; islamelayat@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 17, 2025
• Study Start: August 10, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: beginning after publication and for 6 months ending
• Access Criteria: IPD data will be made available upon reasonable request from the principal investigator.

Locations

EG (1)