Tongue NeoplasmsNCT06169605
Assessment of the Effect of Tumor Thickness and Site on Level IV Cervical Lymph Nodes in Squamous Cell Carcinoma of the Tongue and Floor of the Mouth: A Case Series Study
A study testing removal of primary tumor, neck dissection in people with Tongue Neoplasms, run by Cairo University at 1 site in Egypt.
Trial summary
Regarding oral cavity cancer, the high incidence of neck metastasis along with its impact on survival and prognosis are in favor of elective neck dissection. Moreover, occult metastases could develop at lower levels in the neck (levels IV-V) Regarding the tongue, the rate of skip (occult) metastasis involving… Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tongue Neoplasms
- What is being tested?
- removal of primary tumor, neck dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with squamous cell carcinoma of the tongue and floor of the mouth.
- Age group: from 15 to 60 years old
- No sex predilection
Who cannot join
- Patients with recurrent squamous cell carcinoma of the tongue and floor of the mouth.
- Irradiated patients or those taking chemotherapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
Mohamed Shawky, MSc
About this study
Regarding oral cavity cancer, the high incidence of neck metastasis along with its impact on survival and prognosis are in favor of elective neck dissection. Moreover, occult metastases could develop at lower levels in the neck (levels IV-V) Regarding the tongue, the rate of skip (occult) metastasis involving unremoved level IV cervical lymph nodes in squamous cell carcinoma of the tongue ranges from 0 % - 11.4 %. However, no data is available or a correlation between the risk of level IV involvement and the affection of specific tongue subsites or a certain cutoff value of tumor thickness.
- Conditions
- Tongue Neoplasms
- Being tested
- removal of primary tumor, neck dissection
- Medical subject headings
- Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removal of primary tumor, neck dissectionProcedure or surgery
removal of the primary tumor with safety margins and removal of the neck lymph node levels I, II, III and IV. histological assessment of tumor thickness and whether it is associated with positive nodes in level IV or not.
| Study group | Role | What they receive |
|---|---|---|
| Patients with squamous cell carcinoma of the tongue and floor of the mouth | Experimental | Intervention group Receives: Procedure: removal of primary tumor, neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor thickness in mellimeters
histological assessment of tumor thickness of the resected tumor and assessment of level IV lymph nodes
Measured: one week: specimens are submitted immediately after surgery
Number of affected level IV cervical lymph nodes
In each case the specimen will be assessed for level IV lymph nodes affection
Measured: One week : submitted immediately after surgery
Secondary outcomes (1)
affected tongue site in relation to level IV cervical lymph nodes
histological assessment of level IV lymph nodes to determine if it is affected with tumor site on the tongue (lateral border, dorsum, ventral ....) which will be documented before surgery during examination
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Apr 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tongue NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shawky, Cairo University
- Investigators
- Mohamed Shawky, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169605
- Sponsor's protocol ID
- Cairo uni PhD
- Status last verified
- May 2024
- First submitted
- 3 Dec 2023
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will be available upon reasonable request
Publications
Fakih AR, Rao RS, Borges AM, Patel AR. Elective versus therapeutic neck dissection in early carcinoma of the oral tongue. Am J Surg. 1989 Oct;158(4):309-13. doi: 10.1016/0002-9610(89)90122-0.
PubMed 2802032Kligerman J, Lima RA, Soares JR, Prado L, Dias FL, Freitas EQ, Olivatto LO. Supraomohyoid neck dissection in the treatment of T1/T2 squamous cell carcinoma of oral cavity. Am J Surg. 1994 Nov;168(5):391-4. doi: 10.1016/s0002-9610(05)80082-0.
PubMed 7977957Hutchison IL, Ridout F, Cheung SMY, Shah N, Hardee P, Surwald C, Thiruchelvam J, Cheng L, Mellor TK, Brennan PA, Baldwin AJ, Shaw RJ, Halfpenny W, Danford M, Whitley S, Smith G, Bailey MW, Woodwards B, Patel M, McManners J, Chan CH, Burns A, Praveen P, Camilleri AC, Avery C, Putnam G, Jones K, Webster K, Smith WP, Edge C, McVicar I, Grew N, Hislop S, Kalavrezos N, Martin IC, Hackshaw A. Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort. Br J Cancer. 2019 Nov;121(10):827-836. doi: 10.1038/s41416-019-0587-2. Epub 2019 Oct 15.
PubMed 31611612Shah JP, Candela FC, Poddar AK. The patterns of cervical lymph node metastases from squamous carcinoma of the oral cavity. Cancer. 1990 Jul 1;66(1):109-13. doi: 10.1002/1097-0142(19900701)66:13.0.co;2-a.
PubMed 2354399Dias FL, Lima RA, Kligerman J, Farias TP, Soares JR, Manfro G, Sa GM. Relevance of skip metastases for squamous cell carcinoma of the oral tongue and the floor of the mouth. Otolaryngol Head Neck Surg. 2006 Mar;134(3):460-5. doi: 10.1016/j.otohns.2005.09.025.
PubMed 16500445Matos LL, Manfro G, Santos RV, Stabenow E, Mello ES, Alves VA, Pinto FR, Kulcsar MA, Brandao LG, Cernea CR. Tumor thickness as a predictive factor of lymph node metastasis and disease recurrence in T1N0 and T2N0 squamous cell carcinoma of the oral tongue. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Aug;118(2):209-17. doi: 10.1016/j.oooo.2014.03.023. Epub 2014 Apr 12.
PubMed 24906946
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Tumor Thickness and Site on Level IV Cervical Lymph Nodes in Squamous Cell Carcinoma of the Tongue and Floor of the Mouth: A Case Series Study
- ClinicalTrials.gov ID
- NCT06169605
- Acronym / sponsor ID
- Cairo uni PhD
- Conditions
- Tongue Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 13 Dec 2023 (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.
Regarding oral cavity cancer, the high incidence of neck metastasis along with its impact on survival and prognosis are in favor of elective neck dissection. Moreover, occult metastases could develop at lower levels in the neck (levels IV-V) Regarding the tongue, the rate of skip (occult) metastasis involving unremoved level IV cervical lymph nodes in squamous cell carcinoma of the tongue ranges from 0 % - 11.4 %. However, no data is available or a correlation between the risk of level IV involvement and the affection of specific tongue subsites or a certain cutoff value of tumor thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with squamous cell carcinoma of the tongue and floor of the mouth | Experimental | Procedure: removal of primary tumor, neck dissectionIntervention group |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with squamous cell carcinoma of the tongue and floor of the mouth.
- Age group: from 15 to 60 years old
- No sex predilection
Key exclusion criteria (2 listed)
- Patients with recurrent squamous cell carcinoma of the tongue and floor of the mouth.
- Irradiated patients or those taking chemotherapy.
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 |
|---|---|---|
| removal of primary tumor, neck dissectionremoval of the primary tumor with safety margins and removal of the neck lymph node levels I, II, III and IV. histological assessment of tumor thickness and whether it is associated with positive nodes in level IV or not. | Procedure or surgery | Patients with squamous cell carcinoma of the tongue and floor of the mouth |
Primary outcome
tumor thickness in mellimeters
Time frame: one week: specimens are submitted immediately after surgery
histological assessment of tumor thickness of the resected tumor and assessment of level IV lymph nodes
Number of affected level IV cervical lymph nodes
Time frame: One week : submitted immediately after surgery
In each case the specimen will be assessed for level IV lymph nodes affection
1 secondary outcome
affected tongue site in relation to level IV cervical lymph nodes
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 2802032Fakih AR, Rao RS, Borges AM, Patel AR. Elective versus therapeutic neck dissection in early carcinoma of the oral tongue. Am J Surg. 1989 Oct;158(4):309-13. doi: 10.1016/0002-9610(89)90122-0.
- Background: PubMed 7977957Kligerman J, Lima RA, Soares JR, Prado L, Dias FL, Freitas EQ, Olivatto LO. Supraomohyoid neck dissection in the treatment of T1/T2 squamous cell carcinoma of oral cavity. Am J Surg. 1994 Nov;168(5):391-4. doi: 10.1016/s0002-9610(05)80082-0.
- Background: PubMed 31611612Hutchison IL, Ridout F, Cheung SMY, Shah N, Hardee P, Surwald C, Thiruchelvam J, Cheng L, Mellor TK, Brennan PA, Baldwin AJ, Shaw RJ, Halfpenny W, Danford M, Whitley S, Smith G, Bailey MW, Woodwards B, Patel M, McManners J, Chan CH, Burns A, Praveen P, Camilleri AC, Avery C, Putnam G, Jones K, Webster K, Smith WP, Edge C, McVicar I, Grew N, Hislop S, Kalavrezos N, Martin IC, Hackshaw A. Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort. Br J Cancer. 2019 Nov;121(10):827-836. doi: 10.1038/s41416-019-0587-2. Epub 2019 Oct 15.
- Background: PubMed 2354399Shah JP, Candela FC, Poddar AK. The patterns of cervical lymph node metastases from squamous carcinoma of the oral cavity. Cancer. 1990 Jul 1;66(1):109-13. doi: 10.1002/1097-0142(19900701)66:13.0.co;2-a.
- Background: PubMed 16500445Dias FL, Lima RA, Kligerman J, Farias TP, Soares JR, Manfro G, Sa GM. Relevance of skip metastases for squamous cell carcinoma of the oral tongue and the floor of the mouth. Otolaryngol Head Neck Surg. 2006 Mar;134(3):460-5. doi: 10.1016/j.otohns.2005.09.025.
- Background: PubMed 24906946Matos LL, Manfro G, Santos RV, Stabenow E, Mello ES, Alves VA, Pinto FR, Kulcsar MA, Brandao LG, Cernea CR. Tumor thickness as a predictive factor of lymph node metastasis and disease recurrence in T1N0 and T2N0 squamous cell carcinoma of the oral tongue. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Aug;118(2):209-17. doi: 10.1016/j.oooo.2014.03.023. Epub 2014 Apr 12.
- Individual participant dataSharing planned: Yes. will be available upon reasonable request
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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. This study is not recruiting at the moment.
Mohamed Shawky, MSc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing removal of primary tumor, neck dissection in people with Tongue Neoplasms, run by Cairo 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Shawky, MSc (+201223933897, m.shawky1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor thickness in mellimeters (time frame: one week: specimens are submitted immediately after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06169605, which also lists 6 linked publications.
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 29 May 2024.