Scientific Concept of the National Cohort (status ... - Nationale Kohorte
Scientific Concept of the National Cohort (status ... - Nationale Kohorte
Scientific Concept of the National Cohort (status ... - Nationale Kohorte
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C.1<br />
C.1 Annex: Description <strong>of</strong> <strong>the</strong> study centers<br />
such as <strong>the</strong> renowned heart center, more than half a million inpatients and outpatients are<br />
served per year.<br />
The Institute <strong>of</strong> medical Informatics, Statistics, and Epidemiology (IMISE) comprises<br />
strong expertise in clinical trials and biometry, medical informatics, and systems biology<br />
and bioinformatics. IMISE is involved in research networks such as “Verbundprojekt ‘Familiärer<br />
Darmkrebs’” and “Deutsche Studiengruppe für hochmaligne Non-Hodgkin Lymphome”<br />
(DSNHL). IMISE <strong>of</strong>fshoots include <strong>the</strong> Center for Clinical Studies (ZKS), conducting more<br />
than 100 investigator-initiated or industry-led clinical trials, and <strong>the</strong> Interdisciplinary Center<br />
for Bioinformatics (IZBI). A main goal <strong>of</strong> IMISE is to contribute to improving health care and<br />
medical science through high-quality clinical trials and research into pathomechanisms <strong>of</strong><br />
disease. In addition to <strong>the</strong> scientific expertise required in this context, a strong IT infrastructure<br />
has been established.<br />
The Institute <strong>of</strong> laboratory medicine, Clinical Chemistry, and molecular diagnostics<br />
(ILM) with its accredited laboratories provides a wide range <strong>of</strong> laboratory diagnostic services<br />
for <strong>the</strong> university hospitals and beyond. ILM performs newborn screening for <strong>the</strong> states<br />
<strong>of</strong> Saxony and Thuringia, is involved in numerous clinical trials as <strong>the</strong> central laboratory, and<br />
has a strong research agenda, for instance, for CVD.<br />
IMISE and ILM have been leading partners in establishing <strong>the</strong> “Leipzig Research Center<br />
for Diseases <strong>of</strong> Civilization” (LIFE). In LIFE, population cohorts <strong>of</strong> children and adults are<br />
recruited along with several disease cohorts, totaling more than 20,000 individuals. Detailed<br />
phenotypic characterization <strong>of</strong> participants comprises questionnaires and technical assessments<br />
<strong>of</strong> sociodemographics, disease history, anthropometry, and clinical and laboratory<br />
measurements. LIFE brings toge<strong>the</strong>r scientists from many institutes and clinics and has<br />
strong links to <strong>the</strong> IFB Adiposity Diseases and <strong>the</strong> Max-Planck-Institute for Human Cognitive<br />
and Brain Sciences in Leipzig.<br />
IMISE in conjunction with ILM will run <strong>the</strong> study center Leipzig. Additional epidemiologic<br />
expertise is available from <strong>the</strong> study center Halle. We plan to recruit 10,000 participants for<br />
<strong>the</strong> <strong>National</strong> <strong>Cohort</strong>. In addition to level 1 assessments, assessments for levels 2 and 3 are<br />
envisioned.<br />
Description <strong>of</strong> <strong>the</strong> study center Leipzig<br />
In Leipzig 10,000 individuals will be recruited and will include inhabitants <strong>of</strong> <strong>the</strong> City <strong>of</strong><br />
Leipzig with its population <strong>of</strong> 500,000. A subcohort comprising inhabitants <strong>of</strong> surrounding<br />
rural areas may be established. The study center has been established on <strong>the</strong> medical campus<br />
<strong>of</strong> <strong>the</strong> University <strong>of</strong> Leipzig, about 15 min walking distance to <strong>the</strong> center <strong>of</strong> <strong>the</strong> city. It is<br />
directly accessible by several tram lines, and a bus line and by car, linking <strong>the</strong> center to all<br />
neighborhoods <strong>of</strong> Leipzig as well as to <strong>the</strong> main railway station.<br />
The study center comprises rooms for interviews, questionnaires, anthropometry, ultrasound,<br />
echocardiography, ECG, physical assessments, and preanalytical preparation and<br />
interim storage <strong>of</strong> biosamples. A direct pneumatic delivery link to <strong>the</strong> main laboratory exists.<br />
Currently, IT infrastructure is being established for large cohort studies including data entry<br />
and storage, data transfer from instruments and instant laboratory measurements, and<br />
tracking <strong>of</strong> biomaterials.<br />
The location <strong>of</strong> <strong>the</strong> study center on <strong>the</strong> medical campus <strong>of</strong> <strong>the</strong> University <strong>of</strong> Leipzig facilitates<br />
close cooperation with clinicians and scientists and provides options for additional assessments<br />
for subcohorts in specialized facilities.<br />
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