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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Metastatic Melanoma

Study type: Observational

Funder types: Other

Identifiers

NCT01558349

2012-A00236-37 (Other Identifier)

LOCAL/2011/LM-05

Details and patient eligibility

About

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.

Full 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

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

73 participants in 2 patient groups

Hospitalized controls

Description:

Patients that have been hospitalized at the Nîmes University Hospital and who do not have dermatological cancer.

Metastatic melanoma

Description:

This cohort includes patients with metastatic melanoma.