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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Melanoma

Treatments: Other: Sampling of blood

Study type: Interventional

Funder types: Other

Identifiers

NCT01573494

11-AOI-04

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Metastatic melanoma patients

Experimental group

Description:

Sampling of blood before and after chemotherapy

Treatment:

Other: Sampling of blood