Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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))

Official Title
-----------------
Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients: Impact on Immunity Versus Immunosuppression

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Other: biological collection


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MELANOMA 10mm<br>patients with a melanoma larger than 10mm or with cutaneous metastasis | Other: biological collection<br>* to collect some human cell samples in melanoma<br>* Other names: to collect some human cell samples in melanoma;|
| STAGE III MELANOMA<br>stage III melanoma patients who shall undergo a regional lymph node dissection | Other: biological collection<br>* to collect some human cell samples in melanoma<br>* Other names: to collect some human cell samples in melanoma;|
| SENTINEL NODE PROCEDURE<br>retrospective study of patients who underwent a sentinel node procedure | Other: biological collection<br>* to collect some human cell samples in melanoma<br>* Other names: to collect some human cell samples in melanoma;|
| STAGE IV MELANOMA<br>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 | Other: biological collection<br>* to collect some human cell samples in melanoma<br>* Other names: to collect some human cell samples in melanoma;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of cellular infiltrate - Group 1 | Impact of cellular infiltrate on disease free survival at 2 years | 2 years | 
| Impact of NK cell infiltrate - Group 2 and 3 | Impact of NK cell infiltrate in metastatic lymph node on disease free survival and overall survival at 2 and 3 years | 2 and 3 years | 
| Modifications of cellular infiltrate - Group 4 | Modifications of cellular infiltrate after chemotherapy (after 2 months) | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma, NK cells, T lymphocytes, macrophages