This trial has been completed.

Condition metastatic (stage iv) melanoma
Treatment blood sample
Sponsor Centre Hospitalier Universitaire de Nice
Start date May 2014
End date July 2014
Trial size 22 participants
Trial identifier NCT02133222, 13-AOI-04


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose screening
blood sample

Primary Outcomes

Response to treatment (MRI, Scanner)
time frame: at three months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy.
Principal investigator Elodie LONG-MIRA, PH
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nice.