OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
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|ClinicalTrials.gov Identifier: NCT01961102|
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : August 9, 2016
|Condition or disease||Intervention/treatment|
|Endometrial Cancer Atypical Hyperplasia||Procedure: hysteroscopy/curettage in case of suspicious aspect will be done a rapid section|
If a patient fulfills the inclusion criteria, the surgeon decides intraoperatively due to the aspect in the hysteroscopy if it is a clearly benign result or if it looks suspicious or malign.
In case of a hysteroscopical benign result the patient will be informed about the result after the operation.
In case of a hysteroscopal suspicious or malignant aspect, the curettement will be sent for a rapid section. If the hysteroscopic result confirms the hysteroscopic suspicion the patient will be informed after the operation and the further treatment can be planned right away.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Pilot-study of OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||March 2016|
- Procedure: hysteroscopy/curettage in case of suspicious aspect will be done a rapid section
Other Name: OSCAR Endo Study
- A negative predictive value of 99 % [ Time Frame: Intraoperative ]To get in combination of hysteroscopy and rapid section of the endometrial curettement a negative predictive value of 99% as well as a positive predictive value of 100%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961102
|Department of Gynaecology, Barmherzige Schwestern|
|Linz, Austria, 4020|