Menu
Not yet recruiting NCT07127614

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

— Observational Squamous Cell Carcinoma Mouth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI, Histo-Pathological examination of the resected tumor tissues.
Who it may be relevant to
Registry conditions: Squamous Cell Carcinoma Mouth. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Relationship Between Primary Tumor Depth of Invasion and Neck Lymph Nodes Management in T1T2N0 Oral Cavity Squamous Cell Carcinomas

Overview

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

Detailed description

A diagnostic accuracy study comparing preoperative MRI scans to pathological examination of the resected oral squamous cell carcinoma with lymph nodes to determine the depth of invasion.

Interventions

  • Diagnostic test MRI
    pre-operative MRI scan
  • Diagnostic test Histo-Pathological examination of the resected tumor tissues
    histo-pathological examination of the resected tumor tissues with the lymph nodes involved to determine the pathological depth of invasion

Primary outcome measures

  • Diagnostic accuracy [Time frame: immediately after the surgery]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Egypt · 1 center
  • AL Sayed Galal Hospital Al-Azhar University — Cairo

Identifiers

NCT: NCT07127614 · 1008/2042

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗