Squamous Cell Carcinoma MouthNCT07127614
Primary Tumor Depth of Invasion and Lymph Node Management in Oral Squamous Cell Carcinoma
An observational study of Squamous Cell Carcinoma Mouth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Squamous Cell Carcinoma Mouth
- What is being tested?
- MRI and Histo-Pathological examination of the resected tumor tissues
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2025to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
AL Sayed Galal Hospital Al-Azhar University
Cairo
Islam M Ali, +201274454102, islamelayat@gmail.com
About this study
Official title: The Relationship Between Primary Tumor Depth of Invasion and Neck Lymph Nodes Management in T1T2N0 Oral Cavity Squamous Cell Carcinomas
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
Read the 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.
- Conditions
- Squamous Cell Carcinoma Mouth
- Being tested
- MRI, Histo-Pathological examination of the resected tumor tissues
- Keywords
- squamous cell carcinoma, MRI, diagnostic accuracy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called index test
pre-operative MRI scan
Histo-Pathological examination of the resected tumor tissuesDiagnostic test
Also called Reference test
histo-pathological examination of the resected tumor tissues with the lymph nodes involved to determine the pathological depth of invasion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: MRI; Diagnostic Test: Histo-Pathological examination of the resected tumor tissues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
determination of the diagnostic accuracy of MRI in determining the depth of invasion compared to the pathological depth of invasion
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start10 Aug 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma MouthStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mohamed Mohamed Ali, Al-Azhar University
- Investigators
- Wael A ElMohandes, PhD, Study director, oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar UniversityAhmed M Alfar, PhD, Study chair, oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar UniversityMohamed A Mohamed, PhD, Study chair, oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar UniversityMohamed AW Amin, PhD, Study chair, oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127614
- Sponsor's protocol ID
- 1008/2042
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Individual data sharing
- Yes: Finished results will be published in a scientific journal
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Primary Tumor Depth of Invasion and Neck Lymph Nodes Management in T1T2N0 Oral Cavity Squamous Cell Carcinomas
- ClinicalTrials.gov ID
- NCT07127614
- Acronym / sponsor ID
- 1008/2042
- Conditions
- Squamous Cell Carcinoma Mouth
- Keywords
- squamous cell carcinoma, MRI, diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: MRI, Diagnostic Test: Histo-Pathological examination of the resected tumor tissuesPatients 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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: index testpre-operative MRI scan | Diagnostic test | study group |
| Histo-Pathological examination of the resected tumor tissuesAlso: Reference testhisto-pathological examination of the resected tumor tissues with the lymph nodes involved to determine the pathological depth of invasion | Diagnostic test | study group |
Primary outcome
Diagnostic accuracy
Time frame: immediately after the surgery
determination of the diagnostic accuracy of MRI in determining the depth of invasion compared to the pathological depth of invasion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: Yes. Finished results will be published in a scientific journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wael A ElMohandes, PhD study director
oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar University
Ahmed M Alfar, PhD study chair
oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar University
Mohamed A Mohamed, PhD study chair
oral and maxillofacial surgery, Faculty of Dental Medicine, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma Mouth, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Islam M Ali, MSc (+201274454102, islamelayat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: immediately after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.