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

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ClinicalTrials.gov Identifier: NCT01558349
Recruitment Status : Recruiting
First Posted : March 20, 2012
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief 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.

Condition or disease
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 re-evaluate the 2-CMC per ml blood threshold


Study Type : Observational
Estimated Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques
Study Start Date : June 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. Presence/absence of at least 2 CMCs per ml blood, both techniques [ Time Frame: Day 1 at 8 am ]
    Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques


Secondary Outcome Measures :
  1. CMCs per ml blood, Epispot [ Time Frame: Day 1 at 8 am ]
    The number of CMCs per ml blood as determined by the Epispot technique

  2. CMCs per ml blood, CellSearch [ Time Frame: Day 1 at 8 am ]
    The number of CMCs per ml blood as determined by the CellSearch technique

  3. delta CMC [ Time Frame: Day 1 at 8 am ]
    The difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)

  4. % delta CMC [ Time Frame: Day 1 at 8 am ]
    The % difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)/CellSearch*100

  5. Presence/absence of KI67 antigen markers [ Time Frame: Day 1 at 8 am ]
  6. % cells with S100 protein markers [ Time Frame: Day 1 at 8 am ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: RCB number )
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

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