Trial document




drksid header

  DRKS00010042

Trial Description

start of 1:1-Block title

Title

Detection of cervical intraepithelial neoplasia and HPV infection in women with inflammatory bowel disease

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

Trial Acronym

Detect CD

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

Detection of cervical intraepithelial neoplasia and HPV infection in women with inflammatory bowel disease

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

Brief Summary in Scientific Language

[---]*

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

Organizational Data

  •   DRKS00010042
  •   2016/03/29
  •   [---]*
  •   yes
  •   Approved
  •   16-018, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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

  •   N87.1 -  Moderate cervical dysplasia
  •   K50 -  Crohn disease [regional enteritis]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   A PAP smear and HPV will be taken in women with inflammatory bowel disease
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Frequency of Cervical intraepithelial neoplasia and human paplloma Virus in women with inflammatory bowel disease

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

Secondary Outcome

Factors influencing HPV and CIN

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

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

Recruitment

  •   Actual
  •   2016/04/04
  •   300
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   20   Years
  •   50   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

inflammatory bowel disease

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

Exclusion Criteria

Age, cervical cancer

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Evangelisches Krankenhaus Kalk
    • Mr.  Prof.   Wolgang  Kruis 
    • Buchforststr.2
    • 51103  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0221-82890
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universitätsklinik Köln, Institut für Pathologie
    • Mr.  Prof. Dr.  Reinhard  Büttner 
    • Kerpener Str. 62
    • 50937  Köln
    • 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
    • Evangelisches Krankenhaus Kalk
    • Mr.  Dr.  Dirk M.  Forner 
    • Buchforststr. 2
    • 51103  Köln
    • 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
    • Evangelisches Krankenhaus Kalk
    • Mr.  Dr.  Dirk M.  Forner 
    • Buchforststr. 2
    • 51103  Köln
    • 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
    • Hühnlein- Kurscheid Stiftung
    • Vincenz Statz Str. 6
    • 50933  Köln
    • 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 complete, follow-up complete
  •   2018/12/01
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.