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

Not Applicable

Completed

• Conditions: Melanoma
• Interventions: Other: Sampling of blood

• Registration Number: NCT01573494
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-09
• Study Start: 2012-05
• Primary Completion: 2013-11
• Status Verified: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metastatic melanoma patients	Sampling of blood	Sampling of blood before and after chemotherapy

Primary Outcome Measures

Name	Time	Method
Measuring the number of circulating melanoma cells/ml in blood	baseline and 3 months	Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.

Secondary Outcome Measures

Name	Time	Method
Difference in survival	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.
number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test	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 tumor response	6 months	Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France