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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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).

Condition or disease Intervention/treatment Phase
Malignant Melanoma Stage IV Malignant Melanoma Stage III Biological: quantification of BRAF and NRAS mutation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493230


Contacts
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Contact: Elodie LONG-MIRA, MD 04 92 03 88 55 long-mira.e@chu-nice.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Elodie LONG-MIRA, MD Centre Hospitalier Universitaire de Nice
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03493230    
Other Study ID Numbers: 17-AOI-07
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas