Testing Whether Skin Cancer Has Spread to Nearby Lymph Nodes (CECRE)
Sentinel Lymph Node Biopsy in High-Risk Cutaneous Squamous Cell Carcinoma
This study is about a type of skin cancer called high-risk cutaneous squamous cell carcinoma (HRcSCC). Although most people with this type of skin cancer are successfully treated, some patients have a higher chance that the cancer will spread to nearby lymph nodes. When this happens, treatment becomes more difficult and the chances of recovery are lower.
The aim of this study is to find out whether looking for cancer spread at a very early stage can improve patients' health and survival.
The study focuses on the sentinel lymph node, which is the first lymph node that fluid from the skin tumour reaches. If cancer cells begin to spread, this is usually the first place where they are found. By examining this lymph node, doctors may be able to detect cancer spread before it can be seen on scans or felt during a physical examination.
A total of 142 participants with high-risk skin cancer who have no signs of cancer spread at the time of diagnosis will take part in this study. Participants will be randomly assigned (like flipping a coin) to one of two groups:
Sentinel lymph node biopsy group: Participants will have the usual surgery to remove the skin cancer, together with a small operation to remove the sentinel lymph node. If cancer cells are found in this lymph node, doctors may recommend further treatment, such as surgery to remove additional nearby lymph nodes.
Standard care group: Participants will receive the current standard treatment, which includes surgery to remove skin cancer followed by regular follow-up visits. Further treatment will only be given if there are later signs that the cancer has spread.
Both groups will receive the same regular follow-up care for five years, including medical examinations and imaging tests to check for any signs that the cancer has returned or spread.
Researchers will compare the two groups to determine whether examining the sentinel lymph node helps doctors detect cancer spread earlier, reduces the chance of the cancer returning, and improves long-term survival. The study will also help identify which patients are most likely to benefit from this approach.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona
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Badalona, Barcelona, España, 08916
- Reclutamiento
- Germans Trias i Pujol Universitary Hospital
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Contacto:
- Antonio Navarro, MSc
- Número de teléfono: +34 93 497 88 65
- Correo electrónico: anavarro@igtp.cat
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Contacto:
- Maria Del Río, PhD
- Correo electrónico: mariadelriomd@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Patients with HRcSCC according to the criteria established in the following table.
Diagnosis of HRcSCC will be made if it complies:
- 3 major criteria
- 2 major criteria and 2 minor criteria
- 1 major criteria and 4 minor criteria.
Major clinical criteria: Major histological criteria:
- Dystrophic epidermolysis ampollosa
- Epidermodysplasia verruciforme
- Congenital dyskeratosis Major tumor thickness of 6 mm.
- Pigmentose xeroderm
Oculocutaneous albinism
- Immunosuppression by: Perineural invasion Pulmonary transplantation to heart Hematological disease
- Location: lip, anogenital, atrial pavilion Bone infiltration
- Tumor recurrence
- Major tumor diameter of 5 cm.
- Sign informed consent
Exclusion Criteria:
- - Presence of clinically obvious metastases (N1)
- Concomitan pathologies with high risk of lethality.
- Concomitan pathologies that contraindicate the test.
- Pregnancy
- Breastfeeding
- T3 or T4 of lip are excluded. These patients will be performed cervical lymphadenectomy by protocol.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Conventional treatmeng
Patients with high risk cutaneous squamous cell carcinoma who do not perform SBSG and do not present N1 at the time of diagnosis.
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Experimental: early treatment of subclinical metastases
Lymphadenectomy will be practiced when the selective biopsy of sentinel node (SBSN) is positive (SBSN +).
In patients with T3 or higher N0 and lip carcinoma (since the current protocol indicates performing cervical lymphadenectomy), SBSG will be performed and at the same time of surgery, elective cervical lymphadenectomy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall survival
Periodo de tiempo: Up to 5 years since intervention
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Time (days) elapsed between diagnosis and death of the patient attributable to the disease before the end of the follow-up period.
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Up to 5 years since intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Disease-free time
Periodo de tiempo: Up to 5 years since intervention
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Disease free time: Time (days) elapsed between the end of treatment and the appearance of disease in the form of local, regional and/or remote recurrence.
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Up to 5 years since intervention
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Regional metastases
Periodo de tiempo: Up to 5 years since intervention
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Clinical and/or radiological presence of adenopathies in the territory of tumor drainage including metastases in transit since intervention to 5 years later
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Up to 5 years since intervention
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Remote metastases
Periodo de tiempo: Up to 5 years since intervention
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clinical and/or radiological presence of metastases outside the lymphatic drainage territory
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Up to 5 years since intervention
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Local recurrence
Periodo de tiempo: Up to 5 years since intervention
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reappearance of the lesion in the same location once treated
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Up to 5 years since intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- CECRE
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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