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NCT07127614Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
25 (estimated)
First submitted
30 Jul 2025
Start date
10 Aug 2025
Primary completion date
Jan 2026
Lead sponsor
Al-Azhar University
NCT number
NCT07127614

What you commit to

  • Study type: Observational
  • Planned participants: 25
  • From 10 Aug 2025 to the primary completion date, Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient with gross injury to the neck that precludes proper surgical dissection.
  • Patient with previous neck node biopsy or previous neck dissection

Other illness

  • Patient with a history of radiotherapy to the neck
  • Recurrent cases of OCSCC or recurrent node disease
  • Patient with a medical condition or performance that interferes with the surgical intervention as judged by the specialist physician

Other

  • Patients with T3T4 OCSCC
  • Proven or suspected positive neck node
  • Patient with distant metastasis

Who the study is looking for

  • 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

Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AL Sayed Galal Hospital Al-Azhar University
Coordinator of this site? Confirm its status
CairoEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.