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

NCT01573494 | Completed

• 1 other identifier: 11-AOI-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Cancer; Melanoma; Circulating Tumor Cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test

  3 months

• Difference in survival

  baseline and 6 months

• Difference in tumor response

  6 months

Study Arms (1)

Metastatic melanoma patients

EXPERIMENTAL

Sampling of blood before and after chemotherapy

Other: Sampling of blood

Interventions

Sampling of blood OTHER

7,5 ml of blood

Metastatic melanoma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06202, France

Location

MeSH Terms

Conditions

Melanoma; Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Damien GIACCHERO, PH

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: April 9, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: June 1, 2014
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

FR (1)