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

C.1
C.1 Annex: Description of the study centers
surveys which challenged the concept of fibromyalgia as a distinct rheumatological disease
entity, a large cohort study of initially 10,000 subjects to develop an algorithm to assess
rehabilitation needs of insurants of a regional statutory pension fund for blue collar workers
with severe, disabling BP (Luebeck Algorithm). A previous population-based survey in Hanover
addressed more than 11,000 adult residents of the city studying the prevalence and
health care for rheumatoid arthritis and various rheumatic complaints, including back pain.
Since 1997, the Institute for Cancer Epidemiology (IKE) is running the populationbased
cancer registry of Schleswig-Holstein (in cooperation with the medical association
Schleswig-Holstein). Each year, approximately 20,000 incident cases occur in the area. The
registry processes some 50,000 notifications (mandatory notification) and 30,000 death
certificates per year. Currently more than 600,000 notifications representing more than
250,000 cancer patients are stored in the registry. These data are used for multiple purposes,
including public health reporting, small area analyses, or epidemiologic research.
Furthermore, several large cohort studies were or are being conducted at the institute, as
the worldwide largest controlled cohort study of children conceived after employing artificial
reproductive techniques (ICSI follow-up study = intra cytoplasmatic sperm injection,
n=3,300) or the OVIS study (health care research in cancer survivors, n=5,000). Since
2001, a cohort of women after diagnostic mammography is being built up and analyzed.
Up to now more than 300,000 women have been documented, and a record linkage to the
cancer registry was established.
In 2011 the University of Luebeck launched the recently established Institute for Clinical Epidemiology
(IfKE) (W3 professorship in epidemiology). The new institute will work in close
collaboration with the Institute for Cancer Epidemiology and support the academic center
of population medicine and health care research.
Research activities at Medical Department II of the UzL are focused upon epidemiologic
aspects of cardiac geometry and function and on the molecular genetics of MI. The investigators
have more than 15 years of experience in conducting epidemiologic research in
the context of the MONICA studies. In particular, ECG studies were introduced and repeatedly
carried out in the Augsburg KORA study, producing multiple novel observations. With
respect to MI genetics the group coordinates the German (NGFN, Atherogenomics), European
(EU frame-work 6, Cardiogenics), and global initiatives (CARDIoGRAM) on genomewide
association studies for this pertinent disease.
Description of the study center Kiel
For the National cohort, the Biobank popgen will be responsible for the field work of recruiting
10,000 study participants in Schleswig-Holstein and therefore a study center will be established
at the University Hospital Schleswig-Holstein, campus Kiel. Popgen will be responsible
for all tasks related to recruitment and follow-up, with assistance by the partner institutes at
the CAU and UzL. For example the ICMB will assist in collecting biomaterials whereas IMIS
and SP-PM will supervise ethical and data safety issues. IfSM and IfKE will be responsible
for exposure assessments related to health care research, IKE will be responsible for record
linkages to the cancer registry Schleswig-Holstein during follow-up and the Medical Department
II will be responsible for cardiovascular phenotyping following the general protocol of
the National Cohort. Comprehensive non responder analyses will be done at IfKE.
In Kiel 10,000 individuals will be recruited including inhabitants of the city of Kiel and adjacent
municipalities. The catchment area for the SH cluster will include the city of Kiel
(population 170,000) and adjacent municipalities (population 175,000). This results in a total
source population of about 345,000. Registration offices for drawing random populationbased
samples have been successfully accessed in the past.
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