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Testing Whether Skin Cancer Has Spread to Nearby Lymph Nodes (CECRE)

2026年8月18日 更新者：Germans Trias i Pujol Hospital

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

142

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 西班牙
    • Barcelona
      • Badalona、Barcelona、西班牙、08916
        • 招聘中
        • Germans Trias i Pujol Universitary Hospital
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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:

  1. Dystrophic epidermolysis ampollosa
  2. Epidermodysplasia verruciforme
  3. Congenital dyskeratosis Major tumor thickness of 6 mm.
  4. Pigmentose xeroderm

  5. 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：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.
实验性的：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.
程序：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 node. Approximate cutaneous marking with a permanent marker will be performed to facilitate the intraoperative location of the node.
  2. Surgical intervention will begin with tumor exeresis to prevent interference that hinders the posterior location of the sentinel node. The sentinel node will then be detected with the help of a portable gammagraphic probe. The surgeon will practice a small cutaneous incision through which we will introduce the probe, performing a tracing from more superficial planes to deeper planes. Once located, the sentinel node will be biopsied and is counted on ex vivo radioactivity. In those patients where it is indicated to perform elective cervical lymphadenectomy.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall survival
大体时间：Up to 5 years since intervention
Time (days) elapsed between diagnosis and death of the patient attributable to the disease before the end of the follow-up period.
Up to 5 years since intervention

次要结果测量

结果测量
措施说明
大体时间
Disease-free time
大体时间：Up to 5 years since intervention
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.
Up to 5 years since intervention
Regional metastases
大体时间：Up to 5 years since intervention
Clinical and/or radiological presence of adenopathies in the territory of tumor drainage including metastases in transit since intervention to 5 years later
Up to 5 years since intervention
Remote metastases
大体时间：Up to 5 years since intervention
clinical and/or radiological presence of metastases outside the lymphatic drainage territory
Up to 5 years since intervention
Local recurrence
大体时间：Up to 5 years since intervention
reappearance of the lesion in the same location once treated
Up to 5 years since intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Germans Trias i Pujol Hospital

合作者

Fundació Institut Germans Trias i Pujol

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年7月25日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2028年4月1日

研究注册日期

首次提交

2026年7月28日

首先提交符合 QC 标准的

2026年7月30日

首次发布 (实际的)

2026年8月5日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月18日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CECRE

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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