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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Melanoma

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 Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU de Montpellier - Hopital Saint-Eloi
  • Nîmes Cedex 09, France, 30029
    • CHU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The two cohorts in this study are composed of (1) patients suffering from metastatic melanome and (2) hospitalized patients with no history of cancer.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hospitalized controls; Patients that have been hospitalized at the Nîmes University Hospital and who do not have dermatological cancer.
Metastatic melanoma; This cohort includes patients with metastatic melanoma.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Laurent Meunier, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2013
• Primary Completion (Actual): June 27, 2017
• Study Completion (Actual): June 27, 2017

Study Registration Dates

• First Submitted: March 17, 2012
• First Submitted That Met QC Criteria: March 19, 2012
• First Posted (Estimate): March 20, 2012

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: CellSearch; Epispot; Circulating melanoma cells; circulating cells
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Processes; Neuroendocrine Tumors; Nevi and Melanomas; Neoplasm Metastasis; Melanoma; Neoplastic Cells, Circulating
• Other Study ID Numbers: LOCAL/2011/LM-05; 2011-A01156-35 (Other Identifier: RCB number)