Detection of Plasmatic Cell-free BRAF and NRAS Mutations : a New Tool for Monitoring Patients With Metastatic Malignant Melanoma Treated With Targeted Therapies or Immunotherapy ( MALT ) (MALT)
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|ClinicalTrials.gov Identifier: NCT03493230|
Recruitment Status : Not yet recruiting
First Posted : April 10, 2018
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma Stage IV Malignant Melanoma Stage III||Biological: quantification of BRAF and NRAS mutation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Plasmatic Cell-free BRAF and NRAS Mutations: a New Tool for Monitoring Patients With Metastatic Malignant Melanoma Treated With Targeted Therapies or Immunotherapy ( MALT )|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Patient with malignant melanoma
Patient with advanced or metastatic malignant melanoma (stage IIIB inoperable or IIIC or stage IV) will have a first blood test before any treatment, then at day 15 or 30 after initiation of therapy, and every two months until recurrence or progression for a maximum of 22 months.
Biological: quantification of BRAF and NRAS mutation
Quantification of cell-free BRAF and NRAS mutations with digital PCR
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493230
|Contact: Elodie LONG-MIRA, MD||04 92 03 88 email@example.com|
|Principal Investigator:||Elodie LONG-MIRA, MD||Centre Hospitalier Universitaire de Nice|