Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT01573494
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2012-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Study Overview
Official Title:
Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: