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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic melanoma | Other | Patients with stage III or IV melanoma eligible for an immunotherapy or targeted therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor biopsy | Other | 2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| CD8+ T cells | Dosage of CD8+ T cells | Month 1 before chemotherapy |
| CD8+ T cells | Dosage of CD8+ T cells | Month 1 after chemotherapy |
| expression of ZEB1 protein | Dosage of ZEB 1 protein | Month 1 before chemotherapy |
| expression of ZEB1 protein | Dosage of ZEB 1 protein | Month 1 after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Partial or complete response as assessed by the clinician | Week 13 |
| Progression free survival | Time between the date of treatment initiation and the date of first progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane Dalle, Pr | Contact | 04 78 86 16 79 | +33 | Florence.guillemaud@chu-lyon.fr |
| Myrtille Le Bouar, MSc | Contact | 04 78 86 15 96 | +33 | myrtille.le-bouar@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de dermatologie (Bâtiment 1A) | Recruiting | Lyon | 69495 | France |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood sample | Other | 1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1) |
|
| Week 13 |
| Progression free survival | Time between the date of treatment initiation and the date of first progression | Every year until 5 years |
| overall survival | Time between the date of treatment initiation and the patient death | Week 13 |
| overall survival | Time between the date of treatment initiation and the patient death | Every year until 5 years |
| 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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |