Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients: Impact on Immunity Versus Immunosuppression
概览
- 阶段
- 不适用
- 干预措施
- biological collection
- 疾病 / 适应症
- Melanoma
- 发起方
- Assistance Publique - Hôpitaux de Paris
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Impact of cellular infiltrate - Group 1
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
Melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate with an anti-tumoral specificity. The aim of the study is to analyse at different stages of the disease, tumor samples and to characterise the cellular infiltrate in situ ( in particular T lymphocytes, NK cells and macrophages), the role of inhibitor receptors on in situ immunosuppression, and potential modulation by medical treatments such as dacarbazine.
详细描述
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))
研究者
入排标准
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
MELANOMA 10mm
patients with a melanoma larger than 10mm or with cutaneous metastasis
干预措施: biological collection
STAGE III MELANOMA
stage III melanoma patients who shall undergo a regional lymph node dissection
干预措施: biological collection
SENTINEL NODE PROCEDURE
retrospective study of patients who underwent a sentinel node procedure
干预措施: biological collection
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
干预措施: biological collection
结局指标
主要结局
Impact of cellular infiltrate - Group 1
时间窗: 2 years
Impact of cellular infiltrate on disease free survival at 2 years
Impact of NK cell infiltrate - Group 2 and 3
时间窗: 2 and 3 years
Impact of NK cell infiltrate in metastatic lymph node on disease free survival and overall survival at 2 and 3 years
Modifications of cellular infiltrate - Group 4
时间窗: 2 months
Modifications of cellular infiltrate after chemotherapy (after 2 months)