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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01961102
First Posted: October 11, 2013
Last Update Posted: August 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Krankenhaus Barmherzige Schwestern Linz
  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

Further study details as provided by Krankenhaus Barmherzige Schwestern Linz:

Primary Outcome Measures:
  • A negative predictive value of 99 % [ Time Frame: 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%.


Enrollment: 300
Study Start Date: May 2013
Study Completion Date: March 2016
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961102


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

Responsible Party: Krankenhaus Barmherzige Schwestern Linz
ClinicalTrials.gov Identifier: NCT01961102     History of Changes
Other Study ID Numbers: BHS-Gyn1
First Submitted: October 9, 2013
First Posted: October 11, 2013
Last Update Posted: August 9, 2016
Last Verified: December 2015

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 Neoplasms
Endometrial Hyperplasia
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female