Urimon, study of blood and urine for health monitoring

Urimon is a study in which it will be investigated if it is possible to perform
health monitoring by periodic profiling of microRNA expression levels in urine
and/or blood samples.The hypothesis is that diseases including cancer,
cardiovascular diseases and neurodegenerative disease can be detected in an
early stage this way, before physical complaints become apparent. This
hypothesis is based on the fact that microRNA expression profiles in blood and
urine are relatively stable in healthy individuals. This indicates that
alterations in the expression of diagnostic microRNAs will be picked up more
sensitively when measurements are compared to a baseline determined at health
than if they are compared to the average expression level of the microRNA's in
a larger population (as is the current practice in of disease detection). For
most forms of cancer and the main cardiovascular diseases, multiple diagnostic
micro RNAs have been found in blood. Also in urine diagnostic microRNAs have
been found for multiple types of cancer and cardiovascular diseases. The
alterations in expression levels of these microRNAs can be caused by
alterations in diseased cells, by tissue damage in affected organs or by
activation of the immune system. The expectation, based on this knowledge, is
that the onset of disease in an individual will result in alterations in
microRNA profiles that can signal disease and can specify which disease is
occurring. To what extent alterations in microRNA profiles will overlap in
different persons with the same disease, or in different diseases in the same
person cannot be predicted. This will become clear in the Urimon study.

The goals of the Urimon study is to test the hypothesis that microRNA
expression profiles in periodic urine- and blood samples from individuals can
be used for the sensitive detection of the onset of disease.

To acquire sufficient disease-onset-containing sample series we will collect
3-monthly urine (obligatory for participation) and yearly blood (facultative)
samples from at least 11.000 donors that are healthy and between 45 and 75
years of age at the start of the study, which we will follow for 2 years. Baed
on historical incedence rates, 7% of these people will developed a serious
disease (cancer, cardiovascular disease, neurological disorder). We will test
the hypothesis by determining the microRNA expression profiles, by Next
Generation Sequencing, in the urine and blood samples that were collected prior
to the diagnosis of disease. We will analyse sample series of all ~230 donors
that developed cancer, 230 that developed cardiovascular disease, all donors
(~40) that developed neurological disorder and 230 controls that remained
healthy over the 2 year course of sample donation.

There are no known risks or adverse effects to urine sample collection or
filling out a questionnaire. There are some known risks or adverse effects to
blood sample collection like hematoma which can cause discomfort and pain.
There will be 8 times of urien collection and 9 times to fill out the
questionnaire. Blood will be drawn twice if a participant is willing. The
overall burden for subjects is low in this study.

There is no direct benefit of this study for the participants. The future
benefit for the population could be the development of a health monitoring
method that enables early detection of disease, allowing earlier and less
burdening treatment while increasing chances of cure and leading to lower costs
for society.