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

NCT01336270 | Completed

• 1 other identifier: P090405
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Keywords

Melanoma; NK cells; T lymphocytes; macrophages

Outcome Measures

Primary Outcomes (3)

• Impact of cellular infiltrate - Group 1

  Impact of cellular infiltrate on disease free survival at 2 years

  2 years

• Impact of NK cell infiltrate - Group 2 and 3

  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

  Modifications of cellular infiltrate after chemotherapy (after 2 months)

  2 months

Study Arms (4)

MELANOMA 10mm

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

Other: biological collection

STAGE III MELANOMA

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

Other: biological collection

SENTINEL NODE PROCEDURE

retrospective study of patients who underwent a sentinel node procedure

Other: biological collection

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

Interventions

biological collection OTHER

to collect some human cell samples in melanoma

Also known as: to collect some human cell samples in melanoma

MELANOMA 10mm; SENTINEL NODE PROCEDURE; STAGE III MELANOMA; STAGE IV MELANOMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Cochin Hospital

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

Location

Related Publications (1)

• 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.

  PMID: 26218530 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

A bank of biological samples (human plasma and cells) will be done

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marie Françoise Avril, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 15, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

FR (1)