An interventional study of removal of primary tumor, neck dissection in Tongue Neoplasms, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
1,772 studies on the registry are indexed under Carcinoma, Squamous Cell; 412 are open to participants now.
This study's planned enrollment of 20 is below the median of 44 across 1,414 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Intervention group
Procedure: 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.
tumor thickness in mellimeters
histological assessment of tumor thickness of the resected tumor and assessment of level IV lymph nodes
Time frame: 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
Time frame: One week : submitted immediately after surgery
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
Time frame: One week
Plan to share: Yes — will be available upon reasonable request
Supporting information: Study protocol, Sap
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Cairo University