Trial document




drksid header

  DRKS00004291

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this study is to test various instruments and questionnaires. The results will help in the planning of the National Cohort study which is designed to address research questions concerning a wide range of possible causes of major chronic diseases. The specific aim is to increase understanding of the role of particular risk factors in the development of the following major forms of chronic diseases such as cardiovascular disease, cancer, diabetes, dementia, and infectious diseases, identifying risk factors, highlighting effective forms of prevention, and identifying options for the early detection of diseases and thereby contribute to improving the healthcare of the German population.
200 participants between the ages of 20 and 69 will be recruited. One part will be recruited as random sample by contacting individuals registered in the registry office and the other part will be made up of a convenience sample. The invitation comprises a personal letter and a reply paid envelope.

The invitation letter will entail the study description, aims, the institutions involved, funding agencies as well as the planned study program and the time it will take.
To enable a higher participation rate, inviation letters will be posted and when possible participants will also be contacted by phone to arrange an appointment at the study center. Subjects who agree to participate in the study will undergo the base program and the additional invstigations described here. The entire program is estimated to last 4-5 hours. Pregnant women and women who gave birth in the previous 30 days will be excluded from the vaginal self-sampling study. Patients with arrythmias will be excluded from the dynamic cardiovascular study with Vasoscreen 3000.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Financed by the Federal Ministry of Education and Research (BMBF) and the Federal States in cooperation with the Helmholtz Association and various universities, a large-scale, nationwide, long-term population study will be conducted in Germany in the coming years. The National Cohort will include a total of 200,000 people, aged 20 to 69 years who will be recruited throughout Germany, representing the population of almost all federal states and covering metropolitan, urban and rural regions. The National Cohort is designed to address research questions concerning a wide range of possible causes of major chronic diseases. The objectives spanning the studies to be conducted within the National Cohort will provide a sound basis for establishing improved and more targeted measures for the primary and secondary prevention of major diseases, tailored to the German population.

In preparation of this project various Pretests are scheduled to assess various aspects of the study including the scientific concept and logistics. This would address important questions pertaining to the recruitment of the population, to increase participation in the study and considerations that need to be taken during the implementation phase of the study.
The current study builds on the previously conducted Pretest 1. It comprises feasibility studies which will be conducted at the Hanover study center and other collaborating study centers as an additional project within the Prestest 2 phase of the national cohort study.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004291
  •   2012/08/09
  •   [---]*
  •   yes
  •   Approved
  •   17/2012, Ethikkommission bei der Ärztekammer Niedersachsen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Volunteers
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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 instruments and to modify the instruments available to study requirements. The following studies are planned:

    . Assessing study participant satisfaction with travel to the study center (questionnaire)
    . Optimizing the bring-rate of the immunization card; 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 oral mucosa swabs). Feasibility and acceptance of taking oral mucosa swabs at the study center for the ananlysis of microbial colonization in the oral mucosa.
    . Study on Helicobacter pylori and other gastrointestinal microbes (questionnaire and stool probe at the study center).
    . Cardiovascular investigation- Feasibility and acceptance of dynamic cardiovascular investigation with Vasoscreen 3000.
    . Online interview related to Infections (online- questionnaire).
    . Study related to the acquisition of stool samples. Feasibility and acceptance of giving stool sample at the study center compared to mailing it from home.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
  • other 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2012/08/27
  •   200
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   69   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Helmholtz- Zentrum für Infektionsforschung
    • Mr.  Priv. Doz. Dr.  Frank  Pessler 
    • Feodor-Lynen-Straße 5
    • 30625  Hannover
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universitätsklinikum Hamburg Eppendorf
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Studienzentrum Helmholtz-Zentrum für Infektionsforschung
    • Mr.  Priv.-Doz. Dr. med.  Frank  Pessler 
    • Feodor-Lynen-Straße 5
    • 30625  Hannover
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Studienzentrum des Helmholtz-Zentrums für Infektionsforschung
    • Mr.  Priv.-Doz. Dr. med.  Frank  Pessler 
    • Feodor-Lynen-Straße 5
    • 30625  Hannover
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Helmholtz-Zentrum für Infektionsforschung GmbH
    • Inhoffenstraße 7
    • 38124  Braunschweig
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.