Recruiting

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

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About this study

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.

Condition: Melanoma
Tested: Tumor biopsy, Blood sample
Sponsor: Hospices Civils de Lyon

Who can join

Age: 18 years and older
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 10

Minimum age: 18 years
Study condition: Melanoma
Patient age ≥ 18
Female patients must agree to the use of 2 methods of contraception. For man one method of contraception is needed if if his partner is in childbearing age throughout the study and for at least 5 months after last study treatment administration.
Patients with metastatic stage III or IV melanoma relapse
Eligible for a melanoma metastatic treatment indicated and administered as part of usual care
Patients must be willing and able to undergo cutaneous tumor biopsies (except on the face and folds or lymph node) according to the study protocol
Patient insured or beneficiary of a health insurance plan
Patient able to provide informed consent and sign approved consent forms to participate in the study
Patient accepting the conservation of biological samples and their use for clinical research including genetic research

Exclusion 5

Hematologic tumours under treatment
Patients with a documented history of autoimmune pathology
Ocular melanoma
Persons placed under the safeguard of justice
Use of immunosuppressants including corticosteroids 4 weeks before the inclusion

Where

1 site, 1 recruiting

Service de dermatologie (Bâtiment 1A)

Lyon, France

Recruiting

Contact

Stéphane Dalle, Pr

04 78 86 16 79 Florence.guillemaud@chu-lyon.fr
Myrtille Le Bouar, MSc

04 78 86 15 96 myrtille.le-bouar@chu-lyon.fr

Potential match only. Final eligibility is determined by the study team.