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
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Nice, Frankrike, 06202
- Chu De Nice
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Metastatic melanoma patients
Sampling of blood before and after chemotherapy
|
7,5 ml of blood
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Measuring the number of circulating melanoma cells/ml in blood
Tidsramme: baseline and 3 months
|
Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.
|
baseline and 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test
Tidsramme: 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
Tidsramme: 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.
|
baseline and 6 months
|
|
Difference in tumor response
Tidsramme: 6 months
|
Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.
|
6 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Damien GIACCHERO, PH, Centre Hospitalier Universitaire De Nice
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11-AOI-04
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .