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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAl-Azhar University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • MRI

    Diagnostic test

    pre-operative MRI scan

  • 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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: study group2 interventions

Trial outcomes

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

Time frame
immediately after the surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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