Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients (IMMUMELA)
Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients: Impact on Immunity Versus Immunosuppression
研究概览
详细说明
The study is divided in 4 parts:
Part 1: study of cellular infiltrate (lymphocytes) performed on large primary melanoma and cutaneous metastasis ( fresh samples) Part 2: NK cells study on metastatic regional lymph nodes ( fresh samples) and blood samples Part 3: a retrospective study of macrophages in sentinel lymph nodes and in corresponding primary melanomas Part 4: study of the cellular modulation by the chemotherapy (DTIC or cisplatin or inhibitor of B-raf) which(who) will be made on two cutaneous metastases by patient (one taken before the treatment(processing) and one taken during the evaluation after 2 or 3 cycles of treatment(processing))
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ile de France
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Paris、Ile de France、法国、75014
- Cochin Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients with confirmed melanoma-patients informed of the aims of the study , the modalities
- Patients who signed the consent form ou a non opposition form signed by the patient or by a relative
According to study part:
Part 1: patients with a melanoma larger than 10mm or with cutaneous metastasis Part 2: stage IV melanoma patients who shall undergo a regional lymph node dissection Part 3: retrospective study of patients who underwent a sentinel node procedure Part 4: Patients achieves of inoperable melanomas the stage(stadium) III or IV that must receive in treatment (processing) a chemotherapy (by the dacarbazine or by the cisplatin or by the inhibitor of B-raf) and carrier of at least two cutaneous metastases
Exclusion Criteria:
- Refusal to take part in the study (patient or relative)
- Contraindications known to the xylocaine (groups 1,2, and 4)
- No affiliated to the social security system (groups 1, 2, and 4)
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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MELANOMA 10mm
patients with a melanoma larger than 10mm or with cutaneous metastasis
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to collect some human cell samples in melanoma
其他名称：
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STAGE III MELANOMA
stage III melanoma patients who shall undergo a regional lymph node dissection
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to collect some human cell samples in melanoma
其他名称：
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SENTINEL NODE PROCEDURE
retrospective study of patients who underwent a sentinel node procedure
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to collect some human cell samples in melanoma
其他名称：
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STAGE IV MELANOMA
stage IV patients achieves of inoperable melanomas the stage(stadium) III or IV that must receive in treatment(processing) a chemotherapy (by the dacarbazine or by the cisplatin or by the inhibitor of B-raf) and carrier of at least two cutaneous metastases
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to collect some human cell samples in melanoma
其他名称：
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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 |
|---|---|---|
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Impact of cellular infiltrate - Group 1
大体时间：2 years
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Impact of cellular infiltrate on disease free survival at 2 years
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2 years
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Impact of NK cell infiltrate - Group 2 and 3
大体时间：2 and 3 years
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Impact of NK cell infiltrate in metastatic lymph node on disease free survival and overall survival at 2 and 3 years
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2 and 3 years
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Modifications of cellular infiltrate - Group 4
大体时间：2 months
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Modifications of cellular infiltrate after chemotherapy (after 2 months)
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2 months
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合作者和调查者
调查人员
- 首席研究员：Marie Françoise Avril, MD, PhD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
biological collection的临床试验
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Cliniques universitaires Saint-Luc- Université...Université de Liège招聘中
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GlaxoSmithKline完全的
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GlaxoSmithKline完全的
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GlaxoSmithKlineThe PATH Malaria Vaccine Initiative (MVI)完全的