Clinical trial · Observational
Primary Tumor Depth of Invasion and Lymph Node Management in Oral Squamous Cell Carcinoma
The Relationship Between Primary Tumor Depth of Invasion and Neck Lymph Nodes Management in T1T2N0 Oral Cavity Squamous Cell Carcinomas
NCT07127614CI-TRIAL-00093762not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma Mouth | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histo-Pathological examination of the resected tumor tissues | Diagnostic Test | — | UNRESOLVED |
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- study group
- description
- 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
- interventionNames
- Diagnostic Test: MRI
- Diagnostic Test: Histo-Pathological examination of the resected tumor tissues
Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- immediately after the surgery
- description
- determination of the diagnostic accuracy of MRI in determining the depth of invasion compared to the pathological depth of invasion
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.