Clinical trial · Interventional
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 )
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 )
NCT03493230CI-TRIAL-00087486MALTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quantification of BRAF and NRAS mutation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient with malignant melanoma
- description
- 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.
- interventionNames
- Biological: quantification of BRAF and NRAS mutation
Primary outcomes (2)
- measure
- Quantify plasmatic BRAF and NRAS mutation determine by PCR digitale in µg/ml before treatment
- timeFrame
- Day 0
- measure
- 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 .
- timeFrame
- Month 24
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDde Vries E, Bray FI, Coebergh JW, Parkin DM. Changing epidemiology of malignant cutaneous melanoma in Europe 1953-1997: rising trends in incidence and mortality but recent stabilizations in western Europe and decreases in Scandinavia. Int J Cancer. 2003 Oct 20;107(1):119-26. doi: 10.1002/ijc.11360. PMID 12925966
- BACKGROUNDDhillon AS, Hagan S, Rath O, Kolch W. MAP kinase signalling pathways in cancer. Oncogene. 2007 May 14;26(22):3279-90. doi: 10.1038/sj.onc.1210421. PMID 17496922
- RESULTBahadoran P, Allegra M, Le Duff F, Long-Mira E, Hofman P, Giacchero D, Passeron T, Lacour JP, Ballotti R. Major clinical response to a BRAF inhibitor in a patient with a BRAF L597R-mutated melanoma. J Clin Oncol. 2013 Jul 1;31(19):e324-6. doi: 10.1200/JCO.2012.46.1061. Epub 2013 May 28. No abstract available. PMID 23715574