NCT05029791

Variations of Immune Infiltrate and Cell Plasticity Markers in Treated Metastatic Melanoma Patients

Study of Variations of Immune Infiltrate and Cell Plasticity Markers in Patients With Metastatic Melanoma Under Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
OTHER	Tumor biopsy	2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)
OTHER	Blood sample	1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)

Timeline

• Start date: 2022-08-18
• Primary completion: 2031-11-18
• Completion: 2031-11-18
• First posted: 2021-09-01
• Last updated: 2023-12-15

Locations

1 site across 1 country: France