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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01961102

Enrollment

300

Registered

2013-10-11

Start date

2013-05-31

Completion date

2016-03-31

Last updated

2016-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical Hyperplasia, Endometrial Cancer

Keywords

postmenopausal bleeding, postmenopausal hyperplasia, endometrial cancer, atypical hyperplasia, curettage, intraoperative rapid section

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.

Interventions

PROCEDUREhysteroscopy/curettage in case of suspicious aspect will be done a rapid section

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
A negative predictive value of 99 %	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%.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026