Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. The detection of CTC by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown encouraging results. The investigators propose a prospective study of the CellSearch system in patients with melanoma. Primary objective: To determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma. Secondary objectives: determine the percentage of patients with metastatic melanoma with melanoma cells circulating seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma

Official Title
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Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.

Conditions
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Melanoma

Intervention / Treatment
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* Other: Sampling of blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > or = 18 years Patients with advanced melanoma stage IIIC (unresectable) or stage IV Patient not treated or not responding to chemotherapy with chemotherapy session last> 1 month Patients who signed informed consent Patients presenting no socio-economic, psychological, familial or geographical allow proper understanding of the information leaflet of the protocol or the regular monitoring in the department of dermatology Patients with a life expectancy greater than 3 months Patients with melanoma measurable by RECIST version 1.1 Patients with venous good for venipuncture Exclusion Criteria: Patients with contraindication for treatment with chemotherapy or V600E BRAF inhibitor or ipilimumab or have conditions concomitant heavy may interfere with the treatment of metastatic melanoma Pregnant women or nursing People vulnerable detainees, adults under guardianship or curatorship, minors.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metastatic melanoma patients<br>Sampling of blood before and after chemotherapy | Other: Sampling of blood<br>* 7,5 ml of blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the number of circulating melanoma cells/ml in blood | Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch. | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test | Calculating the number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test before and after treatment. | 3 months | 
| Difference in survival | Difference in survival between patients depending on the number of circulating melanoma cells/ml before treatment, according to Kaplan-Meier method. | baseline and 6 months | 
| Difference in tumor response | Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Melanoma, Circulating Tumor Cells