Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma
NCT03225365
Melanoma, Metastatic Melanoma
Pierre-Bénite, France
View Trial DetailsNCT Number: NCT01558349
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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All sexes
Observational
CHU de Montpellier - Hôpital Saint-Eloi, Montpellier, France
The secondary objectives of this study include:
A. To compare the following elements between the two patient groups:
B. To compare the EPISPOT and CellSearch techniques is terms of the following:
C. To re-evaluate the 2-CMC per ml blood threshold
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for patients:
Inclusion criteria
for controls:
Exclusion criteria
Exclusion criteria
for patients:
Exclusion criteria
for controls:
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
Time frame: Day 1 at 8 am
The number of CMCs per ml blood as determined by the Epispot technique
Time frame: Day 1 at 8 am
The number of CMCs per ml blood as determined by the CellSearch technique
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)
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
Time frame: Day 1 at 8 am
Time frame: Day 1 at 8 am
Centre Hospitalier Universitaire de Nīmes
Other
Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques
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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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