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

Metastatic Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558349
• Other study ID #: LOCAL/2011/LM-05
• Secondary ID: 2011-A01156-35
• Status: Completed
• Start date: June 27, 2013
• Est. completion date: June 27, 2017

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 27, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma
• Neoplastic Cells, Circulating

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Saint-Eloi	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CMCs per ml blood, Epispot	The number of CMCs per ml blood as determined by the Epispot technique	Day 1 at 8 am
Secondary	CMCs per ml blood, CellSearch	The number of CMCs per ml blood as determined by the CellSearch technique	Day 1 at 8 am
Secondary	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
Secondary	% 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
Secondary	Presence/absence of KI67 antigen markers		Day 1 at 8 am
Secondary	% cells with S100 protein markers		Day 1 at 8 am