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

NCT ID: NCT01961102

Last Updated: 2016-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Endometrial Cancer Atypical Hyperplasia

Study Design

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Observational Model Type

CASE_ONLY

Interventions

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

Intervention Type PROCEDURE

Other Intervention Names

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OSCAR Endo Study

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Krankenhaus Barmherzige Schwestern Linz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Gynaecology, Barmherzige Schwestern

Linz, , Austria

Site Status

Countries

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Austria

References

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Hefler-Frischmuth K, Hirtl-Goergl E, Unterrichter V, Lafleur J, Brunnmayr-Petkin G, Moinfar F, Hefler L. One-stop clinical assessment of risk for endometrial hyperplasia (OSCAR-Endo): a fast-track protocol for evaluating endometrial pathologies. Arch Gynecol Obstet. 2017 Apr;295(4):959-964. doi: 10.1007/s00404-017-4326-8. Epub 2017 Mar 6.

Reference Type DERIVED
PMID: 28265757 (View on PubMed)

Other Identifiers

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BHS-Gyn1

Identifier Type: -

Identifier Source: org_study_id

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