Testing Whether Skin Cancer Has Spread to Nearby Lymph Nodes

Официальное название

Selective Biopsy of Sentinel Ganglion in High-risk Cutaneous Squamous Carcinoma

Обзор

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.

Вмешательства

• Процедура Lymphadenectomy
  1. Lymphogampigraphy. A planar lymphogampigraphy will be performed, and Single Photon Emission Computed Tomography (SPECT) study if necessary, to study the location of the lymph node or sentinel ganglia. Approximate cutaneous marking with a permanent marker will be performed to facilitate the intraoperative location of the ganglion. 2. Surgical intervention will begin with tumor exeresis to prevent interference that hinders the posterior location of the sentinel ganglion. The sentinel ganglion w

Первичные конечные точки

• Overall survival [Срок оценки: Up to 5 years since intervention]

Вторичные конечные точки (4)

• Disease-free time [Срок оценки: Up to 5 years since intervention]
• Regional metastases [Срок оценки: Up to 5 years since intervention]
• Remote metastases [Срок оценки: Up to 5 years since intervention]
• Local recurrence [Срок оценки: Up to 5 years since intervention]

Критерии участия

Критерии включения

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

Критерии исключения

• \- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Germans Trias i Pujol Universitary Hospital — Badalona

Идентификаторы

NCT: NCT07746258 · CECRE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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