Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000599

Trial Description

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Title

Prevalence of HPV-infections in women aged 20-25 in Germany

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Trial Acronym

[---]*

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URL of the Trial

http://www.rki.de/cln_151/nn_494662/DE/Content/InfAZ/H/HPV/HPV-Praevalenzstudie.html

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Brief Summary in Lay Language

Amount of HPV-infections in women aged 20 to 25 in Germany.

Prevalence study.
Participants get a a self sampling kit for a cervico-vaginal lavage. The lavage is sent via mail to the lab and tested of HPV. Participants will be informed about their results via mail.

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Brief Summary in Scientific Language

Prevalencestudy of HPV-infections in women aged 20 to 25 in Germany

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Organizational Data

  •   DRKS00000599
  •   2011/03/03
  •   [---]*
  •   yes
  •   Approved
  •   EA2/028/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Infections with Human Papillomavirus
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Study group: HPV test
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Prevalence of HPV-infections in women aged 20-25 in Germany

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Secondary Outcome

Classification of HPV genotypes

GP5+/GP6+-based PCR and luminex-based multiplexed genotyping

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/10/18
  •   780
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   20   Years
  •   25   Years
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Additional Inclusion Criteria

age, female

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Exclusion Criteria

pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Robert Koch-Institut
    • Ms.  Dr. med.  Yvonne   Delere 
    • DGZ-Ring 1
    • 13086  Berlin
    • Germany
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    •   0049 (0) 30 18 754 3410
    •   [---]*
    •   delerey at rki.de
    •   [---]*
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    • Gynäkologische Tumorimmunologie Charité
    • Mr.  PD Dr.  Andreas  Kaufmann 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Robert Koch-Institut
    • Ms.  Dr. med.  Yvonne   Delere 
    • DGZ-Ring 1
    • 13086  Berlin
    • Germany
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    start of 1:1-Block address contact scientific-contact
    •   0049 (0) 30 18 754 3410
    •   [---]*
    •   delerey at rki.de
    •   [---]*
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    • Robert Koch-Institut
    • Ms.  Dr. med.  Yvonne  Deleré 
    • DGZ-Ring 1
    • 13086  Berlin
    • Germany
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    •   0049 (0) 30 18 754 3111
    •   [---]*
    •   delerey at rki.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Robert Koch-Institut
    • DGZ-Ring 1
    • 13086  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/09/30
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Trial Publications, Results and other Documents

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