Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Completed
CT.gov ID
NCT01573494
Collaborator
(none)
30
1
1
25
1.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Sampling of blood
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metastatic melanoma patients

Sampling of blood before and after chemotherapy

Other: Sampling of blood
7,5 ml of blood

Outcome Measures

Primary Outcome Measures

  1. Measuring the number of circulating melanoma cells/ml in blood [baseline and 3 months]

    Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.

Secondary Outcome Measures

  1. number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test [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.

  2. Difference in survival [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.

  3. Difference in tumor response [6 months]

    Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 CHU de Nice Nice France 06202

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

  • Study Director: Damien GIACCHERO, PH, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01573494
Other Study ID Numbers:
  • 11-AOI-04
First Posted:
Apr 9, 2012
Last Update Posted:
Jun 26, 2014
Last Verified:
Jun 1, 2014
Keywords provided by Centre Hospitalier Universitaire de Nice
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2014