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

NCT ID: NCT01336270

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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))

Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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MELANOMA 10mm

patients with a melanoma larger than 10mm or with cutaneous metastasis

biological collection

Intervention Type OTHER

to collect some human cell samples in melanoma

STAGE III MELANOMA

stage III melanoma patients who shall undergo a regional lymph node dissection

biological collection

Intervention Type OTHER

to collect some human cell samples in melanoma

SENTINEL NODE PROCEDURE

retrospective study of patients who underwent a sentinel node procedure

biological collection

Intervention Type OTHER

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

biological collection

Intervention Type OTHER

to collect some human cell samples in melanoma

Interventions

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biological collection

to collect some human cell samples in melanoma

Intervention Type OTHER

Other Intervention Names

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to collect some human cell samples in melanoma

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie Françoise Avril, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Cochin Hospital

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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Messaoudene M, Perier A, Fregni G, Neves E, Zitvogel L, Cremer I, Chanal J, Sastre-Garau X, Deschamps L, Marinho E, Larousserie F, Maubec E, Avril MF, Caignard A. Characterization of the Microenvironment in Positive and Negative Sentinel Lymph Nodes from Melanoma Patients. PLoS One. 2015 Jul 28;10(7):e0133363. doi: 10.1371/journal.pone.0133363. eCollection 2015.

Reference Type RESULT
PMID: 26218530 (View on PubMed)

Other Identifiers

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P090405

Identifier Type: -

Identifier Source: org_study_id

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