Metastatic melanoma.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pathologically proven melanoma, metastasized 2. No prior systemic anti-tumour treatment 3. Being able to give informed consent (time to consider study participation is minimal three days)
Exclusion criteria
Exclusion criteria: 1. Without pathologically proven melanoma 2. Treated with immune-modulating drugs 3. Concomitant chronic diseases that may affect immune system (such as prior or current malignant disease, active infectious disease, rheumatologic diseases, kidney diseases, active allergy etc.) 4. No informed consent 5. Severe anaemia defined as a Hb of less than 6,0 g/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the frequencies and differentiation status of CD4 and CD8 T cell populations (Tnaive, TCM, TEM, TEMRA) in young (18-50) and old (> 65) treatment naive metastasized melanoma patients at baseline. In addition, the frequencies and differentiation of Treg in these two age groups will be assessed. We compare this with data from two age-matched groups healthy controls to distinguish age-factors from melanoma-factors. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To study the presence of markers of the immune risk phenotype in patients (e.g. CD4/CD8-ratio, CMV-status). - To study markers of immune senescence (e.g. CD27, CD28) and exhaustion (e.g. PD1, CTLA-4). - Furthermore, this study increases our understanding of the pathophysiology of behaviour and development of melanoma in elderly and young patients. | — |
Contacts
UMCG Hanzeplein 1