Endometrial NeoplasmsNCT05588076
Endometrial Lesions Predictions
An observational study of Endometrial Neoplasms, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
To explore the risk factors of endometrial lesions in patients with abnormal uterine bleeding and establish prediction models which can discriminate between different endometrial etiologies of abnormal uterine bleeding(AUB). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Endometrial Neoplasms
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Dec 2022
- 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 18 to 60 years
- Women only
- Adult
Study population: This cross-sectional study was approved by the Institutional Ethics Committee and conducted in the Beijing Friendship Hospital, Capital Medical University in China
Who may be able to join
- 1) non-pregnancy related abnormal uttering bleeding（AUB） in women of 18-60 years old; 2)women who had indications for hysteroscopy and endometrial histology in the study period
Who cannot join
- 1) postmenopausal women, 2) AUB due to other causes such as hormones or medications, coagulation disorders, and vascular malformation of the uterus; 3) final diagnosis outside the scope of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors of Endometrial Lesions in Patients With Abnormal Uterine Bleeding
To explore the risk factors of endometrial lesions in patients with abnormal uterine bleeding and establish prediction models which can discriminate between different endometrial etiologies of abnormal uterine bleeding(AUB).
- Conditions
- Endometrial Neoplasms
- Being tested
- no intervention
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| normal endometrial | Not described Receives: Other: no intervention | |
| endometrial lesions | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathology of endometrial lesions
Endometrial tissue was curettaged and sent for pathological examination in 10% formalin. A senior pathologist who was not blinded to clinical and ultrasound information examined the samples and determined the final diagnosis. The outcomes of histology are classified as normal endometrium and endometrial lesions, which include 1)endometrial polyps,2)endometrial hyperplasia without atypia, 3)endometrial atypical hyperplasia and 4) endometrial carcinoma.
Measured: 1 year
Secondary outcomes (1)
Ultrasonographic Examination
VS examinations were performed by an experienced physician with a vaginal probe of 5.5 MHz of a GE VolusonE10 Ultrasound device to look for endometrial thickness and abnormal echoes. Endometrial thickness (ET) was measured at the thickest part with double layers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Oct 2021
- Primary completion1 Oct 2022
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenjing Zhang, Dr, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588076
- Sponsor's protocol ID
- AUBEM
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Endometrial Lesions in Patients With Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT05588076
- Acronym / sponsor ID
- AUBEM
- Conditions
- Endometrial Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Oct 2022 (actual)
- 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.
To explore the risk factors of endometrial lesions in patients with abnormal uterine bleeding and establish prediction models which can discriminate between different endometrial etiologies of abnormal uterine bleeding(AUB).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal endometrial | – | Other: no intervention |
| endometrial lesions | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This cross-sectional study was approved by the Institutional Ethics Committee and conducted in the Beijing Friendship Hospital, Capital Medical University in China
Key inclusion criteria (1 listed)
- 1) non-pregnancy related abnormal uttering bleeding（AUB） in women of 18-60 years old; 2)women who had indications for hysteroscopy and endometrial histology in the study period
Key exclusion criteria (1 listed)
- 1) postmenopausal women, 2) AUB due to other causes such as hormones or medications, coagulation disorders, and vascular malformation of the uterus; 3) final diagnosis outside the scope of this study.
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 |
|---|---|---|
| no interventionno intervention | Other | normal endometrial |
Primary outcome
pathology of endometrial lesions
Time frame: 1 year
Endometrial tissue was curettaged and sent for pathological examination in 10% formalin. A senior pathologist who was not blinded to clinical and ultrasound information examined the samples and determined the final diagnosis. The outcomes of histology are classified as normal endometrium and endometrial lesions, which include 1)endometrial polyps,2)endometrial hyperplasia without atypia, 3)endometrial atypical hyperplasia and 4) endometrial carcinoma.
1 secondary outcome
Ultrasonographic Examination
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Wenjing Zhang, Dr principal investigator
Beijing Friendship Hospital
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 Neoplasms, run by Beijing Friendship Hospital at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Oct 2022. 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 China. 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?
Results are not available in the source record.
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?
pathology of endometrial lesions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2022.