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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Metastatic (Stage IV) Melanoma

Treatments: Procedure: blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02133222

13-AOI-04

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Metastatic (stage IV) melanoma

Experimental group

Treatment:

Procedure: blood sample