Scientific Concept of the National Cohort (status ... - Nationale Kohorte

IX
Executive Summary
able risks, by collecting repeated measurements over time. In many ongoing studies, the
strength of the relationships of key risk factors with disease may have been substantially
biased by not having sufficiently accounted for within-subject variations over time. A less
than full appreciation of the quantitative importance of specific risk factors may cause erroneous
priority setting for prevention. In the National Cohort, the repeated collection of
measurements and biomaterials both over the short term, in calibration sub-studies, and
over the medium term through the 5-year repeat visit of all study participants, will enable us
to quantitatively estimate relative risks more accurately.
2. Studies of the geographic and socio-economic disparities in health status and
disease risks in Germany and possible causes and explanations
Within Germany health status varies significantly across socio-economic strata as defined
by level of formal education, employment status, income, or by ethnicity (i.e., belonging to
immigrant minority groups). Moreover, substantial geographic variations in health status
can be observed. A major general objective for the National Cohort will be to contribute
detailed descriptions of these variations and to improve understanding of their causes. Besides
socio-economic descriptors, environmental, psychosocial and behavioural factors will
be studied as key determinants of social health disparities.
3. Development of risk prediction models for identifying individuals at increased risk of
developing major chronic diseases, so as to allow personalized prevention strategies
Risk prediction models and algorithms for stratification of individuals into categories of lower
and higher risk of developing major chronic diseases can be important tools for personalized
medicine and personalized prevention strategies. The National Cohort will provide
an outstanding resource for studies aiming to develop and/or validate comprehensive risk
models that integrate risk factor information obtained by questionnaires, as well from clinical
measurements and assessments of genetic and other biological markers in blood, urine
and other bio-specimens.
4. Evaluation of markers for early detection of disease and pre-disease phenotypes,
so as to develop effective tools for disease prevention
Detection of chronic disease or subclinical phenotypes at an earlier stage of development
may increase chances of an effective cure, and/or minimize side-effects of treatment.
Stimulated by recent technological advances in the fields of genomics, transcriptomics,
proteomics, metabolomics, and epigenomics, research on bio-markers for early detection
of chronic disease or pre-disease states is becoming a major theme for prevention. The
stored biospecimen collection of the National Cohort will provide a precious resource for the
discovery and validation of novel biomarkers for early disease detection, ensuring a rapid
connection between basic discovery research and its confirmation and validation in appropriately
designed human population studies.
For the National Cohort, strong emphasis is given to methods to optimize specimen collection,
pre-analytical processing, transport and storage, so as to minimize pre-analytical
artifacts and to allow future studies on a large variety of markers.
In addition to bio-markers, the large-scale MR imaging component of National Cohort may
also provide unique opportunities for evaluation and discovery of specific morphological
characteristics that may indicate early stages of disease development.
The sample sizes of the entire cohort and the different sub-cohorts are based on thoroughly
conducted statistical calculations that show that these numbers are sufficient, but also nec-