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Feasibility studies of the Pretest 2 phase of the German National Cohort- A nationwide study for health and frequent diseases in Germany

Feasibility studies of the Pretest 2 phase of the German National Cohort- A nationwide study for health and frequent diseases in Germany

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00004291
Enrollment
200
Registered
2012-08-09
Start date
2012-08-27
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volunteers

Interventions

Group 1: Testing various Instruments/Modules. To test various instruments for data collection and investigating their feasibility in a large scale cohort study in order to choose the most suitable ins
immunization card evaluation. . Study of HPV and other vaginal microbes (Questionnaire and vaginal fluid self-sampling at home with a home-sampling set). . Study on Oral hygiene (Questionnaire and ora

Sponsors

Helmholtz- Zentrum für Infektionsforschung
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 69 Years

Inclusion criteria

Inclusion criteria: Residents from the Hanover city and region who volunteer to participate in the study will be included.

Exclusion criteria

Exclusion criteria: Pregnant women and women who gave birth in the past 30 days will be excluded form the vaginal self-sampling study. Patients with arrythmias will be excluded from the Vasoscreen 3000 study.

Design outcomes

Primary

MeasureTime frame
1. Central functions (such as managing biosamples and quality control) to establish work flows, test and study their feasibilty. 2. To hire and train personel for the purpose of data collection and examining participants. 3. Testing various instruments/modules- testing various instruments for data collection and investigating their feasibility in a large population-based cohort study, to enable the best instruments to be chosen and and to modify existing instruments for the study.

Secondary

MeasureTime frame
1. Vasoscreen 3000: Capture data on changes in autonomic cardiovascular regulation and describe the hemodynamic phenotypes in a population based study. 2. Analysis of microbial colonization of the oral cavity (oral mucosa swabs) with respect to oral hygiene and alcohol consumption. 3. Determination of vaginal infections making use of molecularbiological methods with a particular focus on Human papillomavirus (HPV). In addition, other vaginal pathogens such as Atopobium vaginae, Chlamydia trachomatis, Gardnerella vaginalis will be also be determined (i.e. using Multiplex PCR). 4. Identification of gastrointestinal microbes in stool samples particularly H. pylori (Antigen test) and the detection of various proteins to quality control (e.g. using Proteonomics). 5. Serological assessments of the blood samples collected in the base program, to determine past infections and non-specific auto-antibodies of no diagnostic significance. Determing RNA expression profiles. 6. Identifying microbial populations and biomarkers (e.g. Proteins, RNA molecules) in saliva samples collected in the base program. 7. DNA samples collected in the base program will be subjected to genetic and epigenetic investigations (SNPs, Methylation studies).

Countries

Germany

Contacts

Public ContactFrank Pessler

Studienzentrum des Helmholtz-Zentrums für Infektionsforschung

gesundheitsstudie@helmholtz-hzi.de+49 511-1235950-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026