Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma
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.
- 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
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.|
- Measuring the number of circulating melanoma cells/ml in blood [ Time Frame: baseline and 3 months ]Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.
- number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test [ Time Frame: 3 months ]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.
- Difference in survival [ Time Frame: baseline and 6 months ]Difference in survival between patients depending on the number of circulating melanoma cells/ml before treatment, according to Kaplan-Meier method.
- Difference in tumor response [ Time Frame: 6 months ]Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.
|Study Start Date:||May 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Metastatic melanoma patients
Sampling of blood before and after chemotherapy
Other: Sampling of blood
7,5 ml of blood
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573494
|CHU de Nice|
|Nice, France, 06202|
|Study Director:||Damien GIACCHERO, PH||CHU de Nice|