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Completed

NCT Number: NCT03493230

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 )

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quantification of BRAF and NRAS mutation

Biological

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

Primary outcomes

  1. Quantify plasmatic BRAF and NRAS mutation determine by PCR digitale in µg/ml before treatment

    Time frame: Day 0

  2. 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

Secondary outcomes

  1. Compare the results obtained by PCR digitale from the cell-free with the results on FFPE tissue samples

    Time frame: Month 24

  2. Identify genomic alterations and mutations of resistances in a restricted subgroup of patient by New Generation Sequencing analysis

    Time frame: Month 24

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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 )

Acronym: MALT

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 10, 2018
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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