Clinical trial NCT01558349: Circulating Tumor Cells and Melanoma: Comparing the EPISPOT and CellSearch Techniques
Official title: Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Melanoma
Keywords: Epispot
CellSearch
Circulating melanoma cells
circulating cells
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Presence/absence of at least 2 CMCs per ml blood, both techniques
timeFrame: Day 1 at 8 am
Secondary outcomes:
measure: CMCs per ml blood, Epispot
timeFrame: Day 1 at 8 am
measure: CMCs per ml blood, CellSearch
timeFrame: Day 1 at 8 am
measure: delta CMC
timeFrame: Day 1 at 8 am
measure: % delta CMC
timeFrame: Day 1 at 8 am
measure: Presence/absence of KI67 antigen markers
timeFrame: Day 1 at 8 am
measure: % cells with S100 protein markers
timeFrame: Day 1 at 8 am
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Laurent Meunier, MD
role: PRINCIPAL_INVESTIGATOR
References: