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

NCT01558349 | Completed

• 2 other identifiers: LOCAL/2011/LM-052012-A00236-37
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Melanoma

Keywords

Epispot; CellSearch; Circulating melanoma cells; circulating cells

Outcome Measures

Primary Outcomes (1)

• Presence/absence of at least 2 CMCs per ml blood, both techniques

  Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques

  Day 1 at 8 am

Secondary Outcomes (6)

• CMCs per ml blood, Epispot

  Day 1 at 8 am

• CMCs per ml blood, CellSearch

  Day 1 at 8 am

• delta CMC

  Day 1 at 8 am

• % delta CMC

  Day 1 at 8 am

• Presence/absence of KI67 antigen markers

  Day 1 at 8 am

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Stage 4 melanoma, without other associated neoplasms
• Patient without cancer, nor history of cancer

You may not qualify if:

• The patient is participating in another 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
• Stage 1 to 3 melanoma, or other types of cancer
• History of cancer

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• Cayrefourcq L, De Roeck A, Garcia C, Stoebner PE, Fichel F, Garima F, Perriard F, Daures JP, Meunier L, Alix-Panabieres C. S100-EPISPOT: A New Tool to Detect Viable Circulating Melanoma Cells. Cells. 2019 Jul 20;8(7):755. doi: 10.3390/cells8070755.

  PMID: 31330795 RESULT

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laurent Meunier, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2012
• First Posted: March 20, 2012
• Study Start: June 27, 2013
• Primary Completion: June 27, 2017
• Study Completion: June 27, 2017
• Last Updated: November 19, 2025

Record last verified: 2017-01

Locations

FR (2)