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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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))
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MELANOMA 10mm | patients with a melanoma larger than 10mm or with cutaneous metastasis |
| |
| STAGE III MELANOMA | stage III melanoma patients who shall undergo a regional lymph node dissection |
| |
| SENTINEL NODE PROCEDURE | retrospective study of patients who underwent a sentinel node procedure |
| |
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biological collection | Other | to collect some human cell samples in melanoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Marie Françoise Avril, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin Hospital | Paris | Île-de-France Region | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26218530 | Result | 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. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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A bank of biological samples (human plasma and cells) will be done
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |