Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma
This study is currently recruiting participants.
Verified March 2012 by Centre Hospitalier Universitaire de Nice
Sponsor:
Centre Hospitalier Universitaire de Nice
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01573494
First received: March 23, 2012
Last updated: August 6, 2012
Last verified: March 2012
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Purpose
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
| Condition | Intervention |
|---|---|
|
Melanoma |
Other: Sampling of blood |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma. |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nice:
Primary Outcome Measures:
- Measuring the number of circulating melanoma cells/ml in blood [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.
Secondary Outcome Measures:
- number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Difference in survival [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Difference in survival between patients depending on the number of circulating melanoma cells/ml before treatment, according to Kaplan-Meier method.
- Difference in tumor response [ Time Frame: 6 months ] [ Designated as safety issue: No ]Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metastatic melanoma patients
Sampling of blood before and after chemotherapy
|
Other: Sampling of blood
7,5 ml of blood
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573494
Contacts
| Contact: Damien GIACCHERO, PH | giacchero.d@chu-nice.fr | |
| Contact: Cassandre LANDES | 0492034588 ext +33 | landes.c@chu-nice.fr |
Locations
| France | |
| CHU de Nice | Recruiting |
| Nice, France, 06202 | |
| Contact: Damien GIACCHERO, PH giacchero.d@chu-nice.fr | |
| Contact: Cassandre LANDES 0492034588 ext +33 landes.c@chu-nice.fr | |
| Principal Investigator: Damien GIACCHERO, PH | |
| Sub-Investigator: Philippe BAHADORAN, PU PH | |
| Sub-Investigator: Thierry PASSERON, PU PH | |
| Sub-Investigator: Jean Philippe LACOUR, PU PH | |
| Sub-Investigator: Laura SILLARD, PH | |
| Sub-Investigator: Florence LE DUFF, PH | |
| Sub-Investigator: Paul HOFMAN, PU PH | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
| Study Director: | Damien GIACCHERO, PH | CHU de Nice |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01573494 History of Changes |
| Other Study ID Numbers: | 11-AOI-04 |
| Study First Received: | March 23, 2012 |
| Last Updated: | August 6, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire de Nice:
|
Cancer Melanoma Circulating Tumor Cells |
Additional relevant MeSH terms:
|
Melanoma Neoplastic Cells, Circulating Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Neoplasm Metastasis Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013