Clinical trial NCT01573494: Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma
Official title: Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: Cancer
Melanoma
Circulating Tumor Cells
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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.

Primary outcomes:
measure: Measuring the number of circulating melanoma cells/ml in blood
timeFrame: baseline and 3 months
Secondary outcomes:
measure: number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test
timeFrame: 3 months
measure: Difference in survival
timeFrame: baseline and 6 months
measure: Difference in tumor response
timeFrame: 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Damien GIACCHERO, PH
role: STUDY_DIRECTOR
References: