Feasibility and quality development of biomaterials in the pretest studies of the German National Cohort

• Published in: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Gesundheitsforschung, Gesundheitsschutz, 2014-11, Vol.57 (11), p.1255-1263
• Main Authors: Kühn, A., Nieters, A., Köttgen, A., Goek, O.N., Michels, K., Nöthlings, U., Jacobs, G., Meisinger, C., Pessler, F., Akmatov, M.F., Kühnisch, J., Moebus, S., Glocker, E., Naus, S., Keimling, M., Leitzmann, M., Linseisen, J., Sarioglu, H., von Toerne, C., Hauck, S.M., Wallaschofski, H., Wichmann, H.E., Illig, Thomas
• Format: Article
• Language: English
• Subjects: Adult; Aged; Biomarkers - analysis; Chronic Disease - epidemiology; Chronic Disease - prevention & control; Cohort Studies; Family Medicine; Feasibility Studies; Female; General Practice; Germany - epidemiology; Humans; Leitthema • Main topic; Male; Medicine; Medicine & Public Health; Middle Aged; Population Surveillance - methods; Public Health; Quality Assurance, Health Care - statistics & numerical data; Specimen Handling - standards; Specimen Handling - statistics & numerical data; Young Adult
• ISSN: 1436-9990; 1437-1588
• DOI: 10.1007/s00103-014-2048-7

Background The German National Cohort (GNC) is designed to address research questions concerning a wide range of possible causes of major chronic diseases (e.g. cancer, diabetes, infectious, allergic, neurologic and cardiovascular diseases) as well as to identify risk factors and prognostic biomarkers for early diagnosis and prevention of these diseases. The collection of biomaterials in combination with extensive information from questionnaires and medical examinations represents one of the central study components. Objectives In two pretest studies of the German National Cohort conducted between 2011 and 2013, a range of biomaterials from a defined number of participants was collected. Ten study centres were involved in pretest 1 and 18 study centres were involved in pretest 2. Standard operation procedures (SOP) were developed and evaluated to minimize pre-analytical artefacts during biosample collection. Within the pretest studies different aspects concerning feasibility of sample collection/preparation [pretest 1 (a)] and quality control of biomarkers and proteome analyses were investigated [pretest 1 (b), (c)]. Additionally, recruitment of study participants for specific projects and examination procedures of all study centres in a defined time period according to common standards as well as transportation and decentralized storage of biological samples were tested (pretest 2). These analyses will serve as the basis for the biomaterial collection in the main study of the GNC starting in 2014. Materials and methods Participants, randomly chosen from the population ( n  = 1000 subjects recruited at ten study sites in pretest 1) were asked to donate blood, urine, saliva and stool samples. Additionally, nasal and oropharyngeal swabs were collected at the study sites and nasal swabs were collected by the participants at home. SOPs for sample collection, preparation, storage and transportation were developed and adopted for pretest 2. In pretest 2, 18 study sites ( n  = 599 subjects) collected biomaterials mostly identical to pretest 1. Biomarker analyses to test the quality of the biomaterials were performed. Results In pretest 1 and 2, it was feasible to collect all biomaterials from nearly all invited participants without major problems. The mean response rate of the subjects was 95 %. As one important result we found for example that after blood draw the cellular fraction should be separated from the plasma and serum fractions during the first hour wit