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 )

Not Applicable

• Conditions: Malignant Melanoma Stage IV; Malignant Melanoma Stage III
• Interventions: Biological: quantification of BRAF and NRAS mutation

• Registration Number: NCT03493230
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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).

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-26
• Study Start: 2018-04
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-10
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-12
• Primary Completion: 2022-04
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients in metastatic situation for a malignant melanoma inoperable stage IIIB or IIIC or stage IV
• In first line of treatment by a targeted therapy (only or in association) or immunotherapy
• Every histological types of cutaneous or mucous malignant melanoma (excepted choroid melanomas)
• The tumor must be mutates for BRAF or NRAS
• The mutation status must have been realized in the Laboratory Pathology Clinical and Experimental (LPCE) of the CHU de Nice analysis of the status on-site metastatic mutational and/or primitive tumor must
• Membership or beneficiary of the national insurance scheme

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Exclusion Criteria

• Histories of cancer or other synchronous cancer
• Pregnant, breast-feeding Women. A pregnancy test will be practiced to the women old enough to procreate.
• Vulnerable People: adults under guardianship, patients deprived of freedom, minor

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with malignant melanoma	quantification of BRAF and NRAS mutation	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.

Primary Outcome Measures

Name	Time	Method
Quantify plasmatic BRAF and NRAS mutation determine by PCR digitale in µg/ml before treatment	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 .	Month 24

Secondary Outcome Measures

Name	Time	Method
Compare the results obtained by PCR digitale from the cell-free with the results on FFPE tissue samples	Month 24
Identify genomic alterations and mutations of resistances in a restricted subgroup of patient by New Generation Sequencing analysis	Month 24