- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01573494
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Nice, France, 06202
- Chu de Nice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metastatic melanoma patients
Sampling of blood before and after chemotherapy
|
7,5 ml of blood
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring the number of circulating melanoma cells/ml in blood
Time Frame: baseline and 3 months
|
Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.
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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
Time Frame: 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.
|
3 months
|
Difference in survival
Time Frame: 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.
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baseline and 6 months
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Difference in tumor response
Time Frame: 6 months
|
Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.
|
6 months
|
Collaborators and Investigators
Investigators
- Study Director: Damien GIACCHERO, PH, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-AOI-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
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