Variations of Immune Infiltrate and Cell Plasticity Markers in Treated Metastatic Melanoma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tumor biopsy, Blood sample.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of Variations of Immune Infiltrate and Cell Plasticity Markers in Patients With Metastatic Melanoma Under Treatment
Overview
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.
Interventions
- 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)
Primary outcome measures
- CD8+ T cells [Time frame: Month 1 before chemotherapy]
- CD8+ T cells [Time frame: Month 1 after chemotherapy]
- expression of ZEB1 protein [Time frame: Month 1 before chemotherapy]
- expression of ZEB1 protein [Time frame: Month 1 after chemotherapy]
Secondary outcome measures (5)
- Clinical response [Time frame: Week 13]
- Progression free survival [Time frame: Week 13]
- Progression free survival [Time frame: Every year until 5 years]
- overall survival [Time frame: Week 13]
- overall survival [Time frame: Every year until 5 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Service de dermatologie (Bâtiment 1A) — Lyon
Identifiers
NCT: NCT05029791 · 69HCL21_0906