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

Primary Purpose

Melanoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sampling of blood
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Melanoma focused on measuring Cancer, Melanoma, Circulating Tumor Cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metastatic melanoma patients

Arm Description

Sampling of blood before and after chemotherapy

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
March 23, 2012
Last Updated
June 25, 2014
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01573494
Brief Title
Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma
Official Title
Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Cancer, Melanoma, Circulating Tumor Cells

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metastatic melanoma patients
Arm Type
Experimental
Arm Description
Sampling of blood before and after chemotherapy
Intervention Type
Other
Intervention Name(s)
Sampling of blood
Intervention Description
7,5 ml of blood
Primary Outcome Measure Information:
Title
Measuring the number of circulating melanoma cells/ml in blood
Description
Measuring the number of circulating melanoma cells/ml in the peripheral blood by the test before and after treatment CellSearch.
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
number of patients who test positive detection of circulating melanoma cells measured in peripheral blood with the CellSearch test
Description
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.
Time Frame
3 months
Title
Difference in survival
Description
Difference in survival between patients depending on the number of circulating melanoma cells/ml before treatment, according to Kaplan-Meier method.
Time Frame
baseline and 6 months
Title
Difference in tumor response
Description
Difference in tumor response between patients according to the variation of circulating melanoma cells/ml before and after treatment.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien GIACCHERO, PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06202
Country
France

12. IPD Sharing Statement

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

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