NCT01558349已完成不适用
Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2013年6月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Presence/absence of at least 2 CMCs per ml blood, both techniques
研究概览
简要总结
The main objective of this study is to compare results for the detection of circulating melanoma cells (CMC) using CellSearch versus EPISPOT (EPithelial ImmunoSPOT) techniques between a group of patients with metastatic melanoma and a group of hospitalized control patients.
详细描述
The secondary objectives of this study include:
A. To compare the following elements between the two patient groups:
- the number of CMCs per ml of blood as determined by EPISPOT
- the number of CMCs per ml of blood as determined by CellSearch
- the percentage of patients with at least 2 CMCs per ml of blood according to the two techniques
- the % of CMCs expressing KI67
- the % of CMCs expressions S100 (only the EPISPOT technique)
B. To compare the EPISPOT and CellSearch techniques is terms of the following:
- the number of CMCs detected per ml blood
- the number of CMCs expressing antigen KI67
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available, within the hours of his/her normally scheduled medical care, for blood sampling at 8 am and 4 pm on the same day.
- •Inclusion Criteria for patients:
- •Stage 4 melanoma, without other associated neoplasms
- •Inclusion Criteria for controls:
- •Patient without cancer, nor history of cancer
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient has a contra-indication for a treatment used in this study
- •Exclusion criteria for patients:
- •Stage 1 to 3 melanoma, or other types of cancer
- •Exclusion criteria for controls:
- •History of cancer
结局指标
主要结局
Presence/absence of at least 2 CMCs per ml blood, both techniques
时间窗: Day 1 at 8 am
Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques
次要结局
- % cells with S100 protein markers(Day 1 at 8 am)
- % delta CMC(Day 1 at 8 am)
- Presence/absence of KI67 antigen markers(Day 1 at 8 am)
- CMCs per ml blood, Epispot(Day 1 at 8 am)
- CMCs per ml blood, CellSearch(Day 1 at 8 am)
- delta CMC(Day 1 at 8 am)
研究者
研究点 (2)
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