Sentinel Lymph Node Biopsy in High-Risk Cutaneous Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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.
研究组 & 干预措施
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.
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.
干预措施: Lymphadenectomy (Procedure)
结局指标
主要结局
Overall survival
时间窗: 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.
次要结局
- Disease-free time(Up to 5 years since intervention)
- Regional metastases(Up to 5 years since intervention)
- Remote metastases(Up to 5 years since intervention)
- Local recurrence(Up to 5 years since intervention)