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Completed

NCT Number: NCT01336270

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cochin Hospital

Paris, Île-de-France Region, 75014, France

About this study

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))

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biological collection

Other

to collect some human cell samples in melanoma

Other names: to collect some human cell samples in melanoma

Primary outcomes

  1. Impact of cellular infiltrate - Group 1

    Time frame: 2 years

    Impact of cellular infiltrate on disease free survival at 2 years

  2. 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

  3. Modifications of cellular infiltrate - Group 4

    Time frame: 2 months

    Modifications of cellular infiltrate after chemotherapy (after 2 months)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: IMMUMELA

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Apr 15, 2011
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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