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
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Nice, Frankrijk, 06202
- Chu De Nice
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Metastatic melanoma patients
Sampling of blood before and after chemotherapy
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7,5 ml of blood
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Measuring the number of circulating melanoma cells/ml in blood
Tijdsspanne: baseline and 3 months
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test
Tijdsspanne: 3 months
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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.
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3 months
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Difference in survival
Tijdsspanne: baseline and 6 months
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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
Tijdsspanne: 6 months
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Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.
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6 months
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Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Damien GIACCHERO, PH, Centre Hospitalier Universitaire De Nice
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 11-AOI-04
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