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De rol van veroudering van het immuunsysteem bij het melanoom.


- candidate number17568
- NTR NumberNTR4539
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-apr-2014
- Secondary IDsMETc 2011.388 
- Public TitleDe rol van veroudering van het immuunsysteem bij het melanoom.
- Scientific TitleAge-related changes of the immune system leading to hyporesponsiveness; a major player and predictor for biological behaviour of metastasized melanoma?
- ACRONYMMELAGE
- hypothesisWe hypothesize that age-associated changes of immune function contribute to impaired anti-melanoma immunity and that these changes underlie the higher incidence and the more aggressive behaviour of melanoma in the elderly. We think that the baseline characteristics in treatment naive metastasized melanoma patients show a more senescent immune system as compared to two age-matched groups healthy controls.
- Healt Condition(s) or Problem(s) studiedMelanoma, Metastasis, Immune system
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2012
- planned closingdate1-jan-2016
- Target number of participants30
- Interventionsnone
- Primary outcomeTo 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 outcome- 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.
- Timepoints
- Trial web sitewww.medischeoncologiegroningen.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. R.R.H. Brom, van den
- CONTACT for SCIENTIFIC QUERIESDrs. R.R.H. Brom, van den
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD24-apr-2014 - 21-mei-2014


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