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Clinical Trials/NCT02133222
NCT02133222
Completed
Not Applicable

Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy.

Centre Hospitalier Universitaire de Nice1 site in 1 country22 target enrollmentStarted: May 2014Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Response to treatment (MRI, Scanner)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Response to treatment (MRI, Scanner)

Time Frame: at three months

Comparison between first day and third months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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