Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy (AMMAM)
Primary Purpose
Metastatic (Stage IV) Melanoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional screening trial for Metastatic (Stage IV) Melanoma
Eligibility Criteria
Inclusion Criteria:
- Age>18 years
- Surgical biopsy for histologic diagnostic
- All melanoma subtypes
- Known genotype BRAF V600
- Affiliation social security
- Consent form signed
Exclusion Criteria:
- Patient with histories of cancer or the other synchronous cancer
- Pregnant women
- Breast-feeding women
- Vulnerable patients: major under guardianship; patient deprived of its rights
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metastatic (stage IV) melanoma
Arm Description
Outcomes
Primary Outcome Measures
Response to treatment (MRI, Scanner)
Comparison between first day and third months
Secondary Outcome Measures
Full Information
NCT ID
NCT02133222
First Posted
April 30, 2014
Last Updated
October 20, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02133222
Brief Title
Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy
Acronym
AMMAM
Official Title
Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2016 (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
Therapies that target specific molecules markedly inhibit cancer growth in several malignancies, and provide valuable strategies for the treatment of advanced melanoma. In recent years, BRAF and KIT have become established therapeutic targets in melanoma patients showing activating mutations in these oncogenes. However, it is crucial that genetic mutations present in the melanoma lesions are identified if the investigators are to design tailormade therapies for individual patients. The tumour genotypes that determine the selection of molecular-targeted therapies are usually identified in primary tumours; however, primary tumours are not always representative of metastases. Circulating free DNA may be a source of valuable information because it can be obtained via routine blood sampling, it provides real-time information about a patient's current disease state, and it allows monitoring and molecular characterization before and after chemotherapy. The aim of the study is to determine the mutational status in circulating DNA in melanoma metastatic patients, with the Sequenom Mass Array, a next generation sequencing technology. Results obtained before and after treatment will be compared with the primary tumor genotype.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic (Stage IV) Melanoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metastatic (stage IV) melanoma
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
blood sample
Primary Outcome Measure Information:
Title
Response to treatment (MRI, Scanner)
Description
Comparison between first day and third months
Time Frame
at three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age>18 years
Surgical biopsy for histologic diagnostic
All melanoma subtypes
Known genotype BRAF V600
Affiliation social security
Consent form signed
Exclusion Criteria:
Patient with histories of cancer or the other synchronous cancer
Pregnant women
Breast-feeding women
Vulnerable patients: major under guardianship; patient deprived of its rights
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elodie LONG-MIRA, PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy
We'll reach out to this number within 24 hrs