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
NCT ID: NCT06169605
Last Updated: 2024-05-29
Study Results
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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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-04-01
2025-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with squamous cell carcinoma of the tongue and floor of the mouth
Intervention group
removal of primary tumor, neck dissection
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.
Interventions
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removal of primary tumor, neck dissection
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.
Eligibility Criteria
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Inclusion Criteria
* Age group: from 15 to 60 years old
* No sex predilection
Exclusion Criteria
* Irradiated patients or those taking chemotherapy.
15 Years
60 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Mohamed Shawky
Assistant lecturer
Principal Investigators
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Mohamed Shawky, MSc
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Faculty of Dentistry, Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Mohamed Shawky, MSc
Role: primary
References
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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.
Kligerman 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.
Hutchison 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.
Shah 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.
Dias 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.
Matos 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.
Other Identifiers
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Cairo uni PhD
Identifier Type: -
Identifier Source: org_study_id
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