Endometrial CancerNCT01961102
OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
An observational study of Endometrial Cancer and Atypical Hyperplasia, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
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%. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Atypical Hyperplasia
- What is being tested?
- hysteroscopy/curettage in case of suspicious aspect will be done a rapid section
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- May 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women
Who may be able to join
- 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
Who cannot join
- Not able to understand and participate in the study
- Premenopausal status
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot-study of 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%.
Read the 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.
- Conditions
- Endometrial Cancer, Atypical Hyperplasia
- Being tested
- hysteroscopy/curettage in case of suspicious aspect will be done a rapid section
- Keywords
- postmenopausal bleeding, postmenopausal hyperplasia, endometrial cancer, atypical hyperplasia, curettage, intraoperative rapid section
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopy/curettage in case of suspicious aspect will be done a rapid sectionProcedure or surgery
Also called OSCAR Endo Study
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961102
- Sponsor's protocol ID
- BHS-Gyn1
- Status last verified
- Dec 2015
- First submitted
- 9 Oct 2013
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28265757
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-study of OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
- ClinicalTrials.gov ID
- NCT01961102
- Acronym / sponsor ID
- BHS-Gyn1
- Conditions
- Endometrial Cancer, Atypical Hyperplasia
- Keywords
- postmenopausal bleeding, postmenopausal hyperplasia, endometrial cancer, atypical hyperplasia, curettage, intraoperative rapid section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Not able to understand and participate in the study
- Premenopausal status
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hysteroscopy/curettage in case of suspicious aspect will be done a rapid sectionAlso: OSCAR Endo Study | Procedure or surgery | – |
Primary outcome
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Derived from this study: PubMed 28265757Hefler-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Atypical Hyperplasia, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A negative predictive value of 99 % (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01961102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.