The main objective of this project is to perform a longitudinal monitoring of BRAF and NRAS cell-free DNA in a large cohort of metastatic melanomas patients before treatment and during the follow-up. Results will be compared with clinical data as imaging (based on RECIST criteria) and the activity of lactate dehydrogenase in serum (LDH).
During a consultation of follow-up for an advanced malignant melanoma (stage IIIb or IIIC or IV), an investigator presents the study to the patient and give him the note of information and the informed consent. The patient can benefit from a reflexion period of of 7 days. In case of agreement, a first blood draw will take place before initiation of any treatment. Between D15 and D30 a second blood draw will be taken. Then a blood draw will be necessary every two months until recurrence or progression of the disease for a maximum of 22 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
35
Quantification of cell-free BRAF and NRAS mutations with digital PCR
nice University hospital
Nice, France
Quantify plasmatic BRAF and NRAS mutation determine by PCR digitale in µg/ml before treatment
Time frame: Day 0
Study the longitudinal monitoring of cell-free the kinetics of the plasma mutation of BRAF and NRAS mutation in µg/ml and comparing them with imaging (based on RECIST criteria) and with the activity of the lactate dehydrogenase in serum ( LDH) in U/l .
Time frame: Month 24
Compare the results obtained by PCR digitale from the cell-free with the results on FFPE tissue samples
Time frame: Month 24
Identify genomic alterations and mutations of resistances in a restricted subgroup of patient by New Generation Sequencing analysis
Time frame: Month 24
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