Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques
18 Years
N/A
Both
Metastatic Melanoma
Trial Information
Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques
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 identify possible diel variations in the number of CMCs with both methods (for (1)
patients and (2) controls with at least two CMCs per ml of blood)
D. To re-evaluate the 2-CMC per ml blood threshold
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Presence/absence of at least 2 CMCs per ml blood, both techniques
Outcome Description:
Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques
Outcome Time Frame:
Day 1 at 8 am
Safety Issue:
No
Principal Investigator
Laurent Meunier, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Hospitalier Universitaire de Nîmes
Authority:
France: Committee for the Protection of Personnes
Study ID:
LOCAL/2011/LM-05
NCT ID:
NCT01558349
Start Date:
June 2013
Completion Date:
June 2014
Related Keywords:
- Metastatic Melanoma
- Epispot
- CellSearch
- Circulating melanoma cells
- circulating cells
- Melanoma
- Neoplastic Cells, Circulating
Name | Location |
|---|
