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

Completed

• Conditions: Melanoma
• Interventions: Other: biological collection

• Registration Number: NCT01336270
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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))

Study Timeline

• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-15
• Study Start: 2011-05
• Primary Completion: 2013-11
• Study Completion: 2014-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-25
• Last Update Posted: 2014-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SENTINEL NODE PROCEDURE	biological collection	retrospective study of patients who underwent a sentinel node procedure
MELANOMA 10mm	biological collection	patients with a melanoma larger than 10mm or with cutaneous metastasis
STAGE III MELANOMA	biological collection	stage III melanoma patients who shall undergo a regional lymph node dissection
STAGE IV MELANOMA	biological collection	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

Primary Outcome Measures

Name	Time	Method
Impact of cellular infiltrate - Group 1	2 years	Impact of cellular infiltrate on disease free survival at 2 years
Impact of NK cell infiltrate - Group 2 and 3	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	2 months	Modifications of cellular infiltrate after chemotherapy (after 2 months)

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, Ile de France, France