The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Uterine Cancers (Endometrial/Cervical) Submitted to Sentinel Lymph Nodes (SLN) Procedure: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Survival (Disease free survival [DFS], overall survival [OS])
研究概览
简要总结
The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined.
This study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed.
This will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Early stage endometrial cancer scheduled for SLN procedure
- •Early stage cervical cancer scheduled for SLN procedure
- •Pathological evaluation of SLNs with standard ultra-staging or one-step nucleic acid amplification (OSNA) for the detection of metastasis
- •Presence of lymph nodes metastasis (macrometastasis or low volume disease [micrometastasis and isolated tumor cells])
排除标准
- •Previous (<5 years) or concomitant malignancy other than non-melanoma skin cancer
- •Advanced/metastatic endometrial cancer
- •Locally advanced/metastatic cervical cancer
结局指标
主要结局
Survival (Disease free survival [DFS], overall survival [OS])
时间窗: through study completion, an average of 3 years
Evaluation of survival outcomes according to the type and volume of lymph nodal disease
Recurrence rate
时间窗: through study completion, an average of 3 year
Evaluation of incidence of recurrences (number of patients having a recurrence) according to the type and volume of lymph nodal disease
次要结局
- Usage of adjuvant therapy in case of small-volume lymph node disease(through study completion, an average of 6 months)
研究者
Fabio Martinelli
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano