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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with malignant melanoma | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quantification of BRAF and NRAS mutation | Biological | Quantification of cell-free BRAF and NRAS mutations with digital PCR |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elodie LONG-MIRA, MD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| nice University hospital | Nice | 06000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12925966 | Background | de 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. | |
| 17496922 | Background |
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| Dhillon 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. |
| 23715574 | Result | Bahadoran 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. |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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