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

Centre Hospitalier Universitaire de Nīmes73 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Melanoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, France

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

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

Time frame: Day 1 at 8 am

Secondary Outcomes

CMCs per ml blood, Epispot

The number of CMCs per ml blood as determined by the Epispot technique

Time frame: Day 1 at 8 am

CMCs per ml blood, CellSearch

The number of CMCs per ml blood as determined by the CellSearch technique

Time frame: 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)

Time frame: 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

Time frame: Day 1 at 8 am

Presence/absence of KI67 antigen markers

Time frame: Day 1 at 8 am

% cells with S100 protein markers

Time frame: Day 1 at 8 am

Data from ClinicalTrials.gov

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