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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01558349

Enrollment

Registered

2012-03-20

Start date

2013-06-27

Completion date

2017-06-27

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Melanoma

Keywords

Epispot, CellSearch, Circulating melanoma cells, circulating cells

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Presence/absence of at least 2 CMCs per ml blood, both techniques	Day 1 at 8 am	Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques

Secondary

Measure	Time frame	Description
CMCs per ml blood, CellSearch	Day 1 at 8 am	The number of CMCs per ml blood as determined by the CellSearch technique
delta CMC	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)
CMCs per ml blood, Epispot	Day 1 at 8 am	The number of CMCs per ml blood as determined by the Epispot technique
Presence/absence of KI67 antigen markers	Day 1 at 8 am	—
% cells with S100 protein markers	Day 1 at 8 am	—
% delta CMC	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

Countries

France

Outcome results