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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01336270

Acronym

IMMUMELA

Enrollment

217

Registered

2011-04-15

Start date

2011-05-01

Completion date

2014-03-01

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Melanoma, NK cells, T lymphocytes, macrophages

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.

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))

Interventions

OTHERbiological collection

to collect some human cell samples in melanoma

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMarie Françoise Avril, MD, PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026