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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961102
• Other study ID #: BHS-Gyn1
• Status: Completed
• Phase: N/A
• First received: October 9, 2013
• Last updated: August 7, 2016
• Start date: May 2013
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: Krankenhaus Barmherzige Schwestern Linz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Atypical Hyperplasia
• Endometrial Cancer
• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hyperplasia

Intervention

Procedure:
• hysteroscopy/curettage in case of suspicious aspect will be done a rapid section

Locations

Country	Name	City	State
Austria	Department of Gynaecology, Barmherzige Schwestern	Linz

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Barmherzige Schwestern Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A negative predictive value of 99 %	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%.	Intraoperative	No