Brief Title
OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
Official Title
Pilot-study of OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
Brief Summary
It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and
intraoperative rapid section a positive predictive value (PPV) regarding the objective
illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative
predictive value (NPV) of 99%.
Detailed Description
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
Primary Outcome
A negative predictive value of 99 %
Condition
Endometrial Cancer
Intervention
hysteroscopy/curettage in case of suspicious aspect will be done a rapid section
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
300
Start Date
May 2013
Completion Date
March 2016
Primary Completion Date
September 2015
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal status (more than 1 year of last menopausal bleeding)
- Postmenopausal vaginal bleeding
- Asymptomatic postmenopausal endometrial hyperplasia
- Understanding of the german language
- Signature and consent of the patient
Exclusion Criteria:
- Not able to understand and participate in the study
- Premenopausal status
- no informed consent
Gender
Female
Ages
45 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01961102
Organization ID
BHS-Gyn1
Responsible Party
Sponsor
Study Sponsor
Krankenhaus Barmherzige Schwestern Linz
Study Sponsor
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Verification Date
December 2015