The objective of the National Cohort study, the largest prospective study ever conducted in Germany, is to provide answers to a broad range of epidemiological questions, to identify risk factors for common diseases and to open up new treatment pathways. This project is being planned since beginning 2009 by the health centers of the Helmholtz Association in a network with partners from universities and other public research institutions.
The objective of this epidemiological study, on a scale unprecedented in Germany, is to provide insights into the causes and risk factors of common diseases, including diabetes, cardiovascular diseases, cancer and neurodegenerative diseases. For the new German cohort, a total of 200,000 study participants will be invited. and followed for a period of twenty-five years. The participants will be invited as a representative random sample of the general population and undergo regular medical examination and provide information about lifestyle and socioeconomic factors.
The biomedical research centers of the Helmholtz Association have taken the initial initiative for the establishment of the National Cohort. This project will be developed in close collaboration with universities and other German research institutions. The German Cancer Research Center (DKFZ, Heidelberg) and the Helmholtz Centre Munich (HMGU), will act as coordinating centres in the planning phase of the cohort study.
The term ‘cohort’ originates from the Roman Empire where it referred to the basic tactical unit of a Roman legion. The National Cohort is also a unit: the study participants consent to participating in the long-term study and will be examined regularly over the next twenty-five years. Questionnaire information will be collected from all study participants, including details on psychosocial factors (e.g., acute or chronic stress, anxiety, social isolation), lifestyle (e.g., physical activity, diet and smoking), medical history and use of medication. All study participants will provide blood and urine samples, which will be stored in a central bio-repository for future research projects.
It is expected that some of the study participants will develop a disease during the duration of the study. These diseases can then be retrospectively related to the data collected up to that point or with a variety of blood and urine based biomarkers. The goal of the National Cohort is to provide answers to a broad range of epidemiological questions, to identify factors for chronic disease risk and to present new pathways for disease prevention. The objectives of this large-scale prospective study tie in with much smaller-scale population studies, such as the Kora study in Augsburg or the mother of such studies, the Framingham Heart Study that began in the USA in 1948.
The estimated total cost of the project amounts to between 150 and 200 million euros. The study was launched in 2009 with a planning and piloting phase of about three years. As from 2012, the recruitment of the cohort will begin.
In addition to the National Cohort, other projects with similar goals have been set up: For example, the European large-scale BBMRI (Biobanking and Biomolecular Resources Research Infrastructure) project will bring together more than 100 biobanks in Europe. This creates the necessary statistical basis for the identification of specific disease markers. The LIFE excellence programme of the University of Leipzig, which has been granted around 38 million euros from the European Regional Development Fund (ERDF), also focuses on this goal. 10,000 healthy citizens from Leipzig as well as more than 17,000 patients will be examined for different disease markers. Genome, transcriptome and metabolome analyses will be used for the project and these will be related to information about lifestyle and environmental factors.
Large-scale cohort projects have also been launched in other countries, for example in Great Britain, Scandinavia, the Netherlands and in the People's Republic of China. The launch of the National Cohort study is an excellent boost for research in Germany since only high case numbers in individual biobanks and the combination of a broad range of skills will be able to close the gap in knowledge between the information gained from human genome sequencing on the one hand and the development of complex diseases on the other.
State-of-the-art biotechnological methods are indispensable for comprehensive approaches focusing on the common goal of cohort and biobank activities, which is to identify disease-associated biomarkers in order to gain a better understanding of the development of complex diseases and use this knowledge for developing methods for the early diagnosis and even prevention of disease.