Circulating Tumor Cells and Melanoma: Comparing the EPISPOT and CellSearch Techniques

Study Overview
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Brief Summary
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The main objective of this study is to compare results for the detection of circulating melanoma cells (CMC) using CellSearch versus EPISPOT (EPithelial ImmunoSPOT) techniques between a group of patients with metastatic melanoma and a group of hospitalized control patients.

Detailed Description
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The secondary objectives of this study include: A. To compare the following elements between the two patient groups: the number of CMCs per ml of blood as determined by EPISPOT the number of CMCs per ml of blood as determined by CellSearch the percentage of patients with at least 2 CMCs per ml of blood according to the two techniques the % of CMCs expressing KI67 the % of CMCs expressions S100 (only the EPISPOT technique) B. To compare the EPISPOT and CellSearch techniques is terms of the following: the number of CMCs detected per ml blood the number of CMCs expressing antigen KI67 C. To re-evaluate the 2-CMC per ml blood threshold

Official Title
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Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques

Conditions
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Metastatic Melanoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available, within the hours of his/her normally scheduled medical care, for blood sampling at 8 am and 4 pm on the same day. Inclusion Criteria for patients: Stage 4 melanoma, without other associated neoplasms Inclusion Criteria for controls: Patient without cancer, nor history of cancer Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding The patient has a contra-indication for a treatment used in this study Exclusion criteria for patients: Stage 1 to 3 melanoma, or other types of cancer Exclusion criteria for controls: History of cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalized controls<br>Patients that have been hospitalized at the Nîmes University Hospital and who do not have dermatological cancer. | |
| Metastatic melanoma<br>This cohort includes patients with metastatic melanoma. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of at least 2 CMCs per ml blood, both techniques | Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques | Day 1 at 8 am | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMCs per ml blood, Epispot | The number of CMCs per ml blood as determined by the Epispot technique | Day 1 at 8 am | 
| CMCs per ml blood, CellSearch | The number of CMCs per ml blood as determined by the CellSearch technique | Day 1 at 8 am | 
| delta CMC | The difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot) | Day 1 at 8 am | 
| % delta CMC | The % difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)/CellSearch*100 | Day 1 at 8 am | 
| Presence/absence of KI67 antigen markers |  | Day 1 at 8 am | 
| % cells with S100 protein markers |  | Day 1 at 8 am | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epispot, CellSearch, Circulating melanoma cells, circulating cells