- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03837613
Prognostic Value of Tumor Thickness of Buccal Mucosa Squamous Cell Carcinoma on the Incidence of Nodal Metastasis.
Prognostic Value of Tumor Thickness of Buccal Mucosa Squamous Cell Carcinoma on the Incidence of Nodal Metastasis in the Neck: A Cohort Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients will be recruited from the outpatient clinics of Al Monofia university hospital, Cairo University Hospital and National Cancer Institute. Patients who fits the inclusion criteria and are motivated and consent to enter the study will be included. Patient recruitment will continue until the target sample size is reached.
Patients data will be collected including personal data, medical history, family history, and classification of the tumor according to the TNM classification system. Patients will be assessed preoperatively with a transcutaneous high frequency probe ultrasound to measure the maximal tumor thickness in millimeters using a 10MHz superficial probe and the lymph nodes in the neck region. In addition to clinical examination and palpation of the neck lymph nodes. Patients will then undergo tumor resection surgery with adequate safety margins under GA with nasotracheal intubation. Selective neck dissection will then be performed. The specimens will be submitted for histopathological examination.
Patients will receive standard post operative care based on the recommendation of the oncologist. Adjunct chemo or radiotherapy will be administered when deemed necessary. Wound care and dressings will be administered as needed.
Patients will be categorized into two groups based on the tumor thickness (exposure).
For the primary outcome, the data source will be the measurement of tumor depth based on Berslow method as discussed in the review of literature, obtained from ultrasonography and recorded in millimeters.Tumor width recorded in (mm) will also be obtained from the ultrasonography as it may be a source of confounders. Further, histological grade of the lesion will also be recorded.
Two confounding factors are highlighted and may be sources of bias and attempt to control for them in the statistical analyses will be made.
Appropriate statistical methods will be used after collection of the data and sources of confounders will be controlled for during analyses in subgroup An attempt to control for tumor width and histological grade in subgroup analyses
All data will be entered electronically. Patients' files are to be stored in numerical order and stored in secure and accessible place. All data will be maintained in storage for 1 year after completion of the study. Data monitoring committee is independent from the sponsor and competing interest.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohamed Ghorab, BDS
- Número de teléfono: 01002841441
- Correo electrónico: ddsmghorab@gmail.com
Ubicaciones de estudio
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Cairo, Egipto, 12111
- Cairo University - Faculty of Oral and Dental Medicine
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Contacto:
- Mohamed Ghorab, BDS
- Número de teléfono: 01002841441
- Correo electrónico: ddsmghorab@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Egyptian patients with BSCC (T all N0) not previously operated or treated with adjunctive therapy. They should present with no clinical signs of neck lymph nodes involvement.
Exclusion Criteria:
- Patients with lesions secondary to another primary site.
- Patients previously removed a primary oral surgery tumor in another site
- Patients with clinical or radiographic evidence of cervical nodal metastases
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Group 1 (TT<4mm)
Patients with a preoperative tumor thickness less than 4 mm.
Intervention: tumor resection and neck dissection
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Surgical removal of the tumor with adequate safety margins.
In addition to neck dissection to dissect the cervical lymph nodes.
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Group 2 (TT >= 4mm)
Patients with a preoperative tumor thickness equal to or more than 4 mm Intervention: tumor resection and neck dissection
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Surgical removal of the tumor with adequate safety margins.
In addition to neck dissection to dissect the cervical lymph nodes.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cervical nodal metastasis
Periodo de tiempo: one week after the surgery
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Number of patients with positive cervical nodal metastasis
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one week after the surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Tumor thickness
Periodo de tiempo: one week after the surgery
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Correlation between the tumor thickness measured preoperatively by ultrasound versus the tumor thickness measured from the histopathological specimen
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one week after the surgery
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mohamed Ghorab, BSD, Cairo University
Publicaciones y enlaces útiles
Publicaciones Generales
- Huang SH, Hwang D, Lockwood G, Goldstein DP, O'Sullivan B. Predictive value of tumor thickness for cervical lymph-node involvement in squamous cell carcinoma of the oral cavity: a meta-analysis of reported studies. Cancer. 2009 Apr 1;115(7):1489-97. doi: 10.1002/cncr.24161.
- Ota Y, Aoki T, Karakida K, Otsuru M, Kurabayashi H, Sasaki M, Nakamura N, Kajiwara H. Determination of deep surgical margin based on anatomical architecture for local control of squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2009 Jul;45(7):605-9. doi: 10.1016/j.oraloncology.2008.08.010. Epub 2008 Nov 20.
- Deshpande G, Das S. Tumor Thickness: A predictor of nodal disease in early squamous cell carcinomas of buccal mucosa. Gulf J Oncolog. 2015 May;1(18):37-43.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MohamedGhorabMSc
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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