RecruitingNot ApplicableNCT05029791

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


Sponsor

Hospices Civils de Lyon

Enrollment

100 participants

Start Date

Aug 18, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This French observational study collects tumor biopsy samples from patients with advanced melanoma (skin cancer) who are starting standard treatment. Researchers analyze how immune cells in and around the tumor change over the course of treatment — aiming to better predict who will respond to therapy. **You may be eligible if...** - You are 18 or older - You have Stage III or IV melanoma (advanced disease) - You are about to start a standard melanoma treatment (prescribed as part of normal care) - You are willing to have skin tumor biopsies taken at specific timepoints - You have health insurance and can give informed consent **You may NOT be eligible if...** - You have an active blood cancer under treatment - You have a documented autoimmune disease - You have ocular (eye) melanoma - You have been on immunosuppressant drugs (including steroids) within 4 weeks of enrolling - You are under legal protection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTumor biopsy

2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)

OTHERBlood sample

1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)


Locations(1)

Service de dermatologie (Bâtiment 1A)

Lyon, France

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NCT05029791


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