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

Completed

• Conditions: Metastatic Melanoma

• Registration Number: NCT01558349
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-03-17
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Study Start: 2013-06-27
• Status Verified: 2017-01
• Primary Completion: 2017-06-27
• Study Completion: 2017-06-27
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence/absence of at least 2 CMCs per ml blood, both techniques	Day 1 at 8 am	Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHU de Montpellier - Hôpital Saint-Eloi; 🇫🇷 Montpellier, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France