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

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.

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

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Other: Sampling of blood

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06202
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metastatic melanoma patients; Sampling of blood before and after chemotherapy	Other: Sampling of blood; 7,5 ml of blood

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Study Director: Damien GIACCHERO, PH, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (Estimate): April 9, 2012

Study Record Updates

• Last Update Posted (Estimate): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Cancer; Melanoma; Circulating Tumor Cells
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Processes; Neuroendocrine Tumors; Nevi and Melanomas; Neoplasm Metastasis; Melanoma; Neoplastic Cells, Circulating
• Other Study ID Numbers: 11-AOI-04