NCT01961102

OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer

Pilot-study of OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Krankenhaus Barmherzige Schwestern Linz · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer
• Atypical Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	hysteroscopy/curettage in case of suspicious aspect will be done a rapid section

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-09-01
• Completion: 2016-03-01
• First posted: 2013-10-11
• Last updated: 2016-08-09

Locations

1 site across 1 country: Austria