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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01558349
First received: March 17, 2012
Last updated: March 4, 2014
Last verified: March 2014

March 17, 2012
March 4, 2014
June 2013
June 2014   (final data collection date for primary outcome measure)
Presence/absence of at least 2 CMCs per ml blood, both techniques [ Time Frame: Day 1 at 8 am ] [ Designated as safety issue: No ]
Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques
Same as current
Complete list of historical versions of study NCT01558349 on ClinicalTrials.gov Archive Site
  • CMCs per ml blood, Epispot [ Time Frame: Day 1 at 8 am ] [ Designated as safety issue: No ]
    The number of CMCs per ml blood as determined by the Epispot technique
  • CMCs per ml blood, CellSearch [ Time Frame: Day 1 at 8 am ] [ Designated as safety issue: No ]
    The number of CMCs per ml blood as determined by the CellSearch technique
  • delta CMC [ Time Frame: Day 1 at 8 am ] [ Designated as safety issue: No ]
    The difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)
  • % delta CMC [ Time Frame: Day 1 at 8 am ] [ Designated as safety issue: No ]
    The % difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)/CellSearch*100
  • Presence/absence of KI67 antigen markers [ Time Frame: Day 1 at 8 am ] [ Designated as safety issue: No ]
  • % cells with S100 protein markers [ Time Frame: Day 1 at 8 am ] [ Designated as safety issue: No ]
  • CMCs per ml blood, Epispot [ Time Frame: Day 1 at 4 pm ] [ Designated as safety issue: No ]
    The number of CMCs per ml blood as determined by the Epispot technique
  • CMCs per ml blood, CellSearch [ Time Frame: Day 1 at 4 pm ] [ Designated as safety issue: No ]
    The number of CMCs per ml blood as determined by the CellSearch technique
  • delta CMC [ Time Frame: Day 1 at 4 pm ] [ Designated as safety issue: No ]
    The difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)
  • % delta CMC [ Time Frame: Day 1 at 4 pm ] [ Designated as safety issue: No ]
    The % difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)/CellSearch*100
  • Presence/absence of at least 2 CMCs per ml blood, both techniques [ Time Frame: Day 1, 4 pm ] [ Designated as safety issue: No ]
    Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques
  • Presence/absence of KI67 markers [ Time Frame: Day 1 at 4 pm ] [ Designated as safety issue: No ]
  • % cells with S100 markers [ Time Frame: Day 1 at 4 pm ] [ Designated as safety issue: No ]
  • Diel difference, Epispot [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The number of CMCs detected via the Epispot technique at 8 am minus that of 4 pm
  • Diel difference, CellSearch [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The number of CMCs detected via the CellSearch technique at 8 am minus that of 4 pm
Same as current
Not Provided
Not Provided
 
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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Metastatic Melanoma
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
82
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Laurent Meunier, MD +33.(0)4.66.68.31.71 laurent.meunier@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr
France
 
NCT01558349
LOCAL/2011/LM-05, 2011-A01156-35
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Laurent Meunier, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP