One-year Recurrence-free Survival of Melanoma Patients Eligible for a Sentinel Lymph Node Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Death or recurrence one year after diagnosis
研究概览
简要总结
Melanoma is one of the most aggressive solid cancers, although mortality can be reduced with early treatment. Immunotherapy has transformed the prognosis of this pathology.
The sentinel lymph node technique is used to classify the severity of melanoma. It is proposed for melanomas with a Breslow thickness of 0.8 mm to 1 mm, and recommended for melanomas greater than 1 mm or with ulceration, whatever the Breslow index.
This technique is particularly useful for assessing pathology by detecting the presence of lymph node metastases. Patients with lymph node involvement (micro or macro) are eligible for adjuvant treatment.
The new recommendations suggest adjuvant immunotherapy for stages IIB and IIC (without lymph node involvement assessed by the sentinel lymph node technique). This procedure is widely used at the CHRU de NANCY.
The aim of this study is to demonstrate the value of the sentinel lymph node in assessing the risk of melanoma recurrence at one year (or more).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Major patient with a melanoma with a Breslow index greater than 0.8mm or ulcerated melanoma, non-metastatic at diagnosis,
排除标准
- •Metastatic patient
- •Minor patient
- •Melanoma with a Breslow index of less than 0.8mm and not ulcerated
- •Patient objecting to data collection
结局指标
主要结局
Death or recurrence one year after diagnosis
时间窗: 1 year
Death or recurrence one year after diagnosis measured through the one-year reassessment (clinical or radiological evaluation).
次要结局
- Overall survival(4 years)
- predictive factors of mortality or recurrence one year after diagnosis(4 years)
- the recurrence-free survival(4 years)
- complications associated with the sentinel lymph node biopsy(4 years)
- recurrence-free survival of patients over 70 years old(4 years)
- post-sentinel lymph node biopsy treatments(4 years)
- the tolerance of adjuvant treatment.(4 years)
研究者
Anne Claire BURSZTEJN
Clinical Professor
Central Hospital, Nancy, France