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Completed

NCT Number: NCT01558349

Circulating Tumor Cells and Melanoma: Comparing the EPISPOT 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Montpellier - Hôpital Saint-Eloi, Montpellier, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2012
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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