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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-10

Study Completion Date

2026-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Squamous Cell Carcinoma Mouth

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

MRI

Intervention Type DIAGNOSTIC_TEST

pre-operative MRI scan

Histo-Pathological examination of the resected tumor tissues

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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MRI

pre-operative MRI scan

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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index test Reference test

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No