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
  Purpose

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.


Condition
Metastatic Melanoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 82
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558349

Contacts
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

Locations
France
CHU de Montpellier - Hôpital Saint-Eloi Not yet recruiting
Montpellier, France, 34295
Sub-Investigator: Catherine Alix-Panabières, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Laurent Meunier, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Laurent Meunier, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01558349     History of Changes
Other Study ID Numbers: LOCAL/2011/LM-05, 2011-A01156-35
Study First Received: March 17, 2012
Last Updated: March 4, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Epispot
CellSearch
Circulating melanoma cells
circulating cells

Additional relevant MeSH terms:
Melanoma
Neoplastic Cells, Circulating
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014