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

NCT ID: NCT01573494

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-06-30

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

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Metastatic melanoma patients

Sampling of blood before and after chemotherapy

Group Type: EXPERIMENTAL

Sampling of blood

Intervention Type: OTHER

7,5 ml of blood

Interventions

Sampling of blood

7,5 ml of blood

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien GIACCHERO, PH

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de Nice

Nice, , France

Countries

France

Other Identifiers

11-AOI-04

Identifier Type: -

Identifier Source: org_study_id