Trial Information
Inclusion Criteria:
- Women between 18 and 80
- Karnofsky-Index of 80 and higher
- Cytological suspicious CIN and a colposcopical impression of a major lesion
(therapeutical endpoint: conisation)
Exclusion Criteria:
- Former malign disease oft he pelvic organs
- Pregnancy
- Serious internistic diseases
- Drug addiction
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
pathological comparative results and all cause mobidity
Outcome Description:
The comparison of these two methods to show that the pathologic diagnostical results are alike and the morbidity is less.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Achim Schneider, Prof. Dr., MPH
Investigator Role:
Study Chair
Investigator Affiliation:
Charité University Berlin, Germany
Authority:
Germany: Ethics Commission
Study ID:
CX-CUR
NCT ID:
NCT01836588
Start Date:
March 2013
Completion Date:
April 2014
Related Keywords:
- CIN
- Cervical Cancer
- Uterine Cervical Neoplasms