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

Assistance Publique - Hôpitaux de Paris217 enrolled

Overview

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.

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))

Study Type

OBSERVATIONAL

Enrollment

217

Conditions

Melanoma

Interventions

biological collectionOTHER

to collect some human cell samples in melanoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Cochin Hospital

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

Impact of cellular infiltrate - Group 1

Impact of cellular infiltrate on disease free survival at 2 years

Time frame: 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

Time frame: 2 and 3 years

Modifications of cellular infiltrate - Group 4

Modifications of cellular infiltrate after chemotherapy (after 2 months)

Time frame: 2 months

Data from ClinicalTrials.gov

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