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

March 4, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75014
        • Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Part 1: patients with a melanoma larger than 10mm or with cutaneous metastasis Part 2: stage III melanoma patients who shall undergo a regional lymph node dissection Part 3: retrospective study of patients who underwent a sentinel node procedure Part 4: stage IV Patient 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MELANOMA 10mm
patients with a melanoma larger than 10mm or with cutaneous metastasis
Other: biological collection
to collect some human cell samples in melanoma
Other Names:
  • to collect some human cell samples in melanoma
STAGE III MELANOMA
stage III melanoma patients who shall undergo a regional lymph node dissection
Other: biological collection
to collect some human cell samples in melanoma
Other Names:
  • to collect some human cell samples in melanoma
SENTINEL NODE PROCEDURE
retrospective study of patients who underwent a sentinel node procedure
Other: biological collection
to collect some human cell samples in melanoma
Other Names:
  • to collect some human cell samples in melanoma
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
Other: biological collection
to collect some human cell samples in melanoma
Other Names:
  • to collect some human cell samples in melanoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of cellular infiltrate - Group 1
Time Frame: 2 years
Impact of cellular infiltrate on disease free survival at 2 years
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
2 and 3 years
Modifications of cellular infiltrate - Group 4
Time Frame: 2 months
Modifications of cellular infiltrate after chemotherapy (after 2 months)
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Marie Françoise Avril, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 14, 2011

First Posted (Estimated)

April 15, 2011

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P090405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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