An observational study in Melanoma, Healthy Volunteers and Microbiome, sponsored by Ardigen. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-20.
Sponsored by Ardigen · Observational
Knowledge about the correlations between the composition of the gut microbiome and a wide range of diseases has substantially increased in recent years. Nonetheless, there is no reference set of information about the microbiome in Poland. The development of such a reference will allow polish scientists conducting research in the field of interaction between gut flora components and such characteristics as lifestyle, certain diseases or patient's responses for treatment. Following the example of such countries as the United States, investigators propose to build a unique set of scientific processed information describing the variability of the polish population microbiome (Polish Microbiome Map). The investigators will provide a reliable dataset that will characterize the gut microbiomes and their diversity in the polish population. Additionally, thanks to the creation of the standard protocol for microbiome data collection the research conducted by the MMP users will be comparable with the information deposited in MMP.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 1,160 is above the median of 182 across 438 observational studies indexed under Melanoma.
Browse Melanoma studies →Ardigen is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers or oncology patients with primary care clinic
Inclusion Criteria for Healthy Volunteers group:
Inclusion Criteria for Melanoma group:
Exclusion Criteria:
This cohort will consist of 1000 healthy volunteers from Poland.
This cohort will consist of 160 patients with melanoma.
Biological: Collection of stool samples
Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
Also known as: Nivolumab, Ipilimumab, Atezolizumab
Microbial diversity in stool samples
Microbial DNA - stool samples sequenced by next-generation sequencing platform.
Time frame: Inclusion
Eating habits and health survey
It includes questions about healthy volunteers' and patients' eating habits that may relate to their health.
Time frame: Inclusion
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Ardigen