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

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.

Full Title of Study: “Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients: Impact on Immunity Versus Immunosuppression”

Study Type

  • Study Type: Observational
  • Study Design
  • Study Primary Completion Date: November 2013

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))

Interventions

  • Other: biological collection
    • to collect some human cell samples in melanoma

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Impact of cellular infiltrate – Group 1
    • Time Frame: 2 years
    • Impact of cellular infiltrate on disease free survival at 2 years
  • Impact of NK cell infiltrate – Group 2 and 3
    • Time Frame: 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
    • Time Frame: 2 months
    • Modifications of cellular infiltrate after chemotherapy (after 2 months)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marie Françoise Avril, MD, PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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