COLEMAN is an opened prospective monocentric non-randomized study, initiated by the Hospices Civils de Lyon. Population targeted are patients from 18 years old with stage III or IV metastatic melanoma eligible for a metastatic melanoma treatment administered as part of usual care. The objective is to study the variations of immune infiltrate and cell plasticity before and under immunotherapy or targeted therapy. Two biopsies are done before and one month after the treatment initiation and one blood sample is done after the treatment initiation. 100 patients will be included and followed during 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
100
2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)
1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)
Service de dermatologie (Bâtiment 1A)
Lyon, France
RECRUITINGCD8+ T cells
Dosage of CD8+ T cells
Time frame: Month 1 before chemotherapy
CD8+ T cells
Dosage of CD8+ T cells
Time frame: Month 1 after chemotherapy
expression of ZEB1 protein
Dosage of ZEB 1 protein
Time frame: Month 1 before chemotherapy
expression of ZEB1 protein
Dosage of ZEB 1 protein
Time frame: Month 1 after chemotherapy
Clinical response
Partial or complete response as assessed by the clinician
Time frame: Week 13
Progression free survival
Time between the date of treatment initiation and the date of first progression
Time frame: Week 13
Progression free survival
Time between the date of treatment initiation and the date of first progression
Time frame: Every year until 5 years
overall survival
Time between the date of treatment initiation and the patient death
Time frame: Week 13
overall survival
Time between the date of treatment initiation and the patient death
Time frame: Every year until 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.