A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
24 de abril de 2026 actualizado por: Jinsong Hou
A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
The purpose of this study is to determine whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
Oral squamous cell carcinoma is the most common malignant tumor of oral and maxillofacial region, and prone to early cervical lymph node metastases.
Lymphatic spread is associated with increased risk of loco-regional recurrence, therefore, the identification of lymph node metastases preoperatively is very important for the optimal surgical therapy.
Recently, cervical lymph node dissection(CLND) is performed in the presence of oral squamous cell carcinoma.
However, whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma is still controversial.
CLND will represent over-treatment in some case of early-stage oral squamous cell carcinoma.
Therefore, How to accurately predict whether a patient should be performed CLND is important.
Our previous study show that tumor budding is closely related to lymphatic spread in the oral squamous cell carcinoma.
The purpose of this study is to find that whether the tumor budding guide the individualized surgical planning of early-stage oral squamous cell carcinoma.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
524
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jinsong Hou, PhD
- Número de teléfono: 86-13825141651
- Correo electrónico: houjsgz@aliyun.com
Copia de seguridad de contactos de estudio
- Nombre: Cheng Wang, PhD
- Número de teléfono: 86-13760853366
- Correo electrónico: drwangcheng@outlook.com
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510055
- Reclutamiento
- Guanghua School of Stomatolagy, Hospital of Stomatology Sun Yat-sen University
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Contacto:
- Jinsong Hou, PhD
- Número de teléfono: 86-13825141651
- Correo electrónico: houjsgz@aliyun.com
-
Contacto:
- Cheng Wang, PhD
- Número de teléfono: 86-13760853366
- Correo electrónico: drwangcheng@outlook.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Han race;
- Oral squamous cell carcinoma is confirmed by pathology;
- The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa;
- The primary lesion is no more than 4cm;
- Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI;
- Patients and families agree to participate in the study;
- Patients do not have cognitive disorders.
Exclusion Criteria:
- Do not meet the inclusion criteria;
- The primary lesion is more than 4cm or invade adjacent tissues;
- Do not review on schedule;
- Patients receive not only surgical procedures, but other antineoplastic treatment;
- There are serious adverse events after operation;
- Patients quit the study voluntarily;
- Patients quit the study because of physical condition.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: High-level tumor budding group with CLND
Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
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Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.
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Experimental: High-level tumor budding group without CLND
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.
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Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.
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Experimental: Low-level tumor budding group with CLND
Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
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Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.
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Experimental: Low-level tumor budding group without CLND
Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.
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Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Five-year survival rate
Periodo de tiempo: After the first year, review every three months at a time；The next four years, review every six months at a time.
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The time from the first operation to death was recorded
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After the first year, review every three months at a time；The next four years, review every six months at a time.
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Disease free survival
Periodo de tiempo: After the first year, review every three months at a time；The next four years, review every six months at a time.
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The time from the start of surgery to the discovery of the first cervical lymphatic metastases
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After the first year, review every three months at a time；The next four years, review every six months at a time.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recurrence rate
Periodo de tiempo: After the first year, review every three months at a time；The next four years, review every six months at a time.
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To investigate the local recurrence rate and the recurrence rate of cervical lymphatic metastasis.
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After the first year, review every three months at a time；The next four years, review every six months at a time.
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Evaluation of quality of life
Periodo de tiempo: After the first year, review every three months at a time；The next four years, review every six months at a time.
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Complete the University of Washington Quality of Life Form (UW-QOL) To understand the quality of life of patients after surgery.
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After the first year, review every three months at a time；The next four years, review every six months at a time.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Jinsong Hou, PhD, Guanghua School of Stomatology, Hospital of Stomatolagy Sun Yat-sen University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Almangush A, Salo T, Hagstrom J, Leivo I. Tumour budding in head and neck squamous cell carcinoma - a systematic review. Histopathology. 2014 Nov;65(5):587-94. doi: 10.1111/his.12471. Epub 2014 Oct 6.
- Almangush A, Bello IO, Keski-Santti H, Makinen LK, Kauppila JH, Pukkila M, Hagstrom J, Laranne J, Tommola S, Nieminen O, Soini Y, Kosma VM, Koivunen P, Grenman R, Leivo I, Salo T. Depth of invasion, tumor budding, and worst pattern of invasion: prognostic indicators in early-stage oral tongue cancer. Head Neck. 2014 Jun;36(6):811-8. doi: 10.1002/hed.23380. Epub 2013 Sep 2.
- Da Sacco L, Masotti A. Recent insights and novel bioinformatics tools to understand the role of microRNAs binding to 5' untranslated region. Int J Mol Sci. 2012 Dec 27;14(1):480-95. doi: 10.3390/ijms14010480.
- Xie N, Wang C, Liu X, Li R, Hou J, Chen X, Huang H. Tumor budding correlates with occult cervical lymph node metastasis and poor prognosis in clinical early-stage tongue squamous cell carcinoma. J Oral Pathol Med. 2015 Apr;44(4):266-72. doi: 10.1111/jop.12242. Epub 2014 Aug 28.
- Hori Y, Kubota A, Yokose T, Furukawa M, Matsushita T, Takita M, Mitsunaga S, Mizoguchi N, Nonaka T, Nakayama Y, Oridate N. Predictive Significance of Tumor Depth and Budding for Late Lymph Node Metastases in Patients with Clinical N0 Early Oral Tongue Carcinoma. Head Neck Pathol. 2017 Dec;11(4):477-486. doi: 10.1007/s12105-017-0814-1. Epub 2017 Apr 3.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
4 de mayo de 2026
Finalización primaria (Estimado)
30 de mayo de 2026
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
15 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
15 de abril de 2016
Publicado por primera vez (Estimado)
19 de abril de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de abril de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HouJ-2015018
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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