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Completed

NCT Number: NCT01961102

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

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%.

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Key information

Conditions

Endometrial Cancer Atypical Hyperplasia Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Gynaecology, Barmherzige Schwestern

Linz, 4020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Other names: OSCAR Endo Study

Primary outcomes

  1. 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%.

Sponsors and collaborators

Lead sponsor

Krankenhaus Barmherzige Schwestern Linz

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 11, 2013
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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