Trial document





This trial has been registered retrospectively.
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  DRKS00000265

Trial Description

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Title

Rhine Saar Study for the comparison of conventional cytology with thinlayer cytology and computerassistance

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Trial Acronym

RSS

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URL of the Trial

http://nicht vorhanden

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Brief Summary in Lay Language

All women insured in the German compulsory health insurance starting their 20th birthday have a legal claim for an annual prevention exam for the early detection of prelesions of cervical cancer. Up to now this is done by a cervical smear which is brought on a glass slide (= Pap smear). The cells on the slide are examined with a microscope. Since several years a new methode is available where this smear is shook into a vial (thinlayer cytology with ThinPrep). The cells in the vial are then transfered to a glass slide, followed by a computer-assisted evaluation. The Rhine-Saar-Study for the first time in Germany will investigate whether this new technique is superior in routine prevention. For that purpose at the usual prevention exam the smear is taken at random in the usual way or according to the new method. In case of a certain degree of abnormality a follow-up is done by colposcopy (examination of the cervix with a magnifying glass).

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Brief Summary in Scientific Language

Randomized study for the improvement of the legal prevention exam for the early detection of prelesions of cervical cancer with thinlayer cytology and computerassistance
The aim of the study is to compare sensitivity and PPV of thinlayer cytology with computerassistance by the Imaging system with that achieved by conventional cytology.
20.000 consecutive women in gynaecologic practices in the Saarland and in Rhineland-Palatinate participating in the routine prevention exam will be divided into two groups. In one half -based on a weekly randomisation- a conventional smear is taken, in the other half a smear for thinlayer cytology. The conventional smears are analysed as usual while the thinlayer specimens are first read as usual and then prescreened with the Imaging system and read a second time. Abnormal findings (cut-off Pap III) will be followed-up by colposcopy and biopsy. Study endpoints are histologically proven CIN2+. A cost-effectiveness analysis is planned.

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Organizational Data

  •   DRKS00000265
  •   2009/12/09
  •   [---]*
  •   [---]*
  •   Approved
  •   837.068.07 (5603), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  •   U1111-1112-5706 
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Health Condition or Problem studied

  •   C53 -  Malignant neoplasm of cervix uteri
  •   N87.1 -  Moderate cervical dysplasia
  •   N87.2 -  Severe cervical dysplasia, not elsewhere classified
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Interventions/Observational Groups

  •   conventional cytology
  •   Thinlayer cytology with ThinPrep system; evaluation by the cytotechnician with and without computer-assistance (Imaging system)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Screening
  •   Parallel
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Primary Outcome

CIN2+

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Secondary Outcome

cost effectiveness analysis

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2007/08/15
  •   20000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   20   Years
  •   no maximum age
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Additional Inclusion Criteria

All women insured by the public health insurance who attended the annual prevention exam in the participating gynaecologic practices

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Exclusion Criteria

hysterektomie, conisation< 3mo, curretage <3mo, radiatio <3mo, participation in the MARZY study

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Addresses

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    • Berufsverband der Frauenärzte e.V. Landesverband Rheinland-Pfalz
    • Berufsverband der Frauenärzte e.V. Landesverband Rheinland-Pfalz 
    • Emmeransstraße 3
    • 55116  Mainz
    • Germany
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    •   06131 22 02 22
    •   06131 23 37 10
    •   [---]*
    •   http://bvf@bvf.de
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    • Hologic Deutschland GmbH (früher: Cytyc Germany)
    • Hologic Deutschland GmbH (früher: Cytyc Germany) 
    • Lyoner Str. 15 / ATRICOM
    • 60528  Frankfurt
    • Germany
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    • Institut für Med. Biometrie und Epidemiologie (IMBEI) Universitätsmedizin Mainz
    • Ms.  Dr. rer. nat.  Stefanie  Klug 
    • Obere Zahlbacher Str. 69
    • 55101  Mainz
    • Germany
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    • Frauenarztpraxis Dr. W. Harlfinger
    • Mr.  Dr. med.  Werner  Harlfinger 
    • Emmeransstr. 3
    • 55116  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Hologic Deutschland GmbH (früher: Cytyc Germany)
    • Hologic Deutschland GmbH (früher: Cytyc Germany) 
    • Lyonerstraße 15 / ATRICOM
    • 60528  Frankfurt
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.