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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Krankenhaus Barmherzige Schwestern Linz
Sponsor:
Information provided by (Responsible Party):
Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier:
NCT01961102
First received: October 9, 2013
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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%.


Condition Intervention
Endometrial Cancer
Atypical Hyperplasia
Procedure: hysteroscopy/curettage in case of suspicious aspect will be done a rapid section

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Pilot-study of OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer

Resource links provided by NLM:


Further study details as provided by Krankenhaus Barmherzige Schwestern Linz:

Primary Outcome Measures:
  • A negative predictive value of 99 % [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    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%.


Estimated Enrollment: 200
Study Start Date: May 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: hysteroscopy/curettage in case of suspicious aspect will be done a rapid section
    Other Name: OSCAR Endo Study
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Postmenopausal women

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961102

Contacts
Contact: Lukas Hefler, Univ.-Doz. 0043 732 7677 ext 7160 lukas.hefler@bhs.at

Locations
Austria
Department of Gynaecology, Barmherzige Schwestern Recruiting
Linz, Austria, 4020
Sponsors and Collaborators
Krankenhaus Barmherzige Schwestern Linz
  More Information

No publications provided

Responsible Party: Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier: NCT01961102     History of Changes
Other Study ID Numbers: BHS-Gyn1
Study First Received: October 9, 2013
Last Updated: January 21, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Krankenhaus Barmherzige Schwestern Linz:
postmenopausal bleeding
postmenopausal hyperplasia
endometrial cancer
atypical hyperplasia
curettage
intraoperative rapid section

Additional relevant MeSH terms:
Hyperplasia
Endometrial Hyperplasia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014