Trial document




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  DRKS00006169

Trial Description

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Title

Comparison of two surgical methods for the treatment of CIN: Classical LLETZ (Large Loop Excision of the Transformation Zone) versus isolated resection of the colposcopic apparent lesion

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Trial Acronym

ECO-ROCS trial
(Evaluation of Clinical Outcome after Reduction of Conization Size)

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

According to national and international guidelines, non-pregnant patients with cervical intraepithelial neoplasia grade 3 (CIN III) should be treated by cervical conization. In accordance with the definition of LLETZ (large loop excision of the transformation zone) the lesion including the transformation zone needs to be resected. It is well known from the literature, that the cone size directly correlates with the risk of preterm delivery in the course of a future pregnancy. The aim of this study is therefore, to analyse if the resection of the lesion only (without additional excision of the transformation zone) is equally effective regarding oncological outcome. Primary endpoint is a negative HPV test 6 and 12 months after the operation.

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Organizational Data

  •   DRKS00006169
  •   2014/07/30
  •   [---]*
  •   yes
  •   Approved
  •   275-14, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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

  •   CIN III
  •   N87.2 -  Severe cervical dysplasia, not elsewhere classified
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Interventions/Observational Groups

  •   LLETZ (Large Loop Excision of the Transformation Zone)
  •   Resection of the dysplastic lesion with no additional resection of the transformation zone
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Negative HPV test 6 and 12 months after the operation

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Secondary Outcome

resection margin of the cone specimen, pap smear 6 and 12 months postop

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2014/09/04
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

CIN III, positive HPV test

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Exclusion Criteria

-pregnancy until 6 months postop
-malignant diseases requiring treatment
-intake of immunosuppressants
-HIV

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Frauenheilkunde und Geburtshilfe Großhadern
    • Mr.  Prof. Dr. med.  Christian  Dannecker 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Pathologisches Institut derLudwig-Maximilians-Universität München
    • Mr.  Prof.  Karl  Sotlar 
    • Thalkirchner Straße 36
    • 80337  München
    • Germany
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    • Charite Berlin Campus Benjamin Franklin
    • Mr.  PD Dr. med.  Andreas  Kaufmann 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Großhadern
    • Ms.  Dr.  Theresa  Kolben 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Großhadern
    • Ms.  Dr.  Theresa  Kolben 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Frauenheilkunde und Geburtshilfe Großhadern
    • Mr.  Prof. Dr. med.  Christian  Dannecker 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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Status

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

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