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 )

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2022-11-08

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Malignant Melanoma Stage IV Malignant Melanoma Stage III

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

quantification of BRAF and NRAS mutation

Intervention Type BIOLOGICAL

Quantification of cell-free BRAF and NRAS mutations with digital PCR

Interventions

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quantification of BRAF and NRAS mutation

Quantification of cell-free BRAF and NRAS mutations with digital PCR

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No