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


N/A
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

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


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))


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

Impact of cellular infiltrate - Group 1

Outcome Description:

Impact of cellular infiltrate on disease free survival at 2 years

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Marie Fran├žoise Avril, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

AP-HP

Authority:

France: Ministry of Health

Study ID:

P090405

NCT ID:

NCT01336270

Start Date:

May 2011

Completion Date:

June 2014

Related Keywords:

  • Melanoma
  • Melanoma
  • NK cells
  • T lymphocytes
  • macrophages
  • Melanoma

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