Endometrial DiseasesNCT03289468
Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases
An observational study of Endometrial Diseases, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The postmenopausal women with vaginal bleeding were selected in this cross-sectional study. The basic characteristics information and endometrial blood flow energy index of endometrium were detected by color power Doppler ultrasound, and the energy histogram of endometrium was obtained. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Endometrial Diseases
- What is being tested?
- Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2017to 30 Dec 2019
- 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 to 80 years
- Women only
- Adult, Older adult
Study population: Postmenopausal women with vaginal bleeding
Who may be able to join
- Postmenopausal women with vaginal bleeding
Who cannot join
- Vaginal bleeding caused by hematological system diseases or genitals outside the uterus
- Uterine bleeding caused by other organ cancers metastasize to the uterus
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Xiaofeng YANG, yxf73@163.com
About this study
The postmenopausal women with vaginal bleeding were selected in this cross-sectional study. The basic characteristics information and endometrial blood flow energy index of endometrium were detected by color power Doppler ultrasound, and the energy histogram of endometrium was obtained. The specimen of uterine cytology and endometrial tissue were obtained through minimally invasive endometrium sampler, which were diagnosed by pathology. The statistical data were used to detect endometrial and precancerous lesions to observe the endpoint, and to provide the energy histogram model of the early warning endothelial diseases.
Read the detailed description
The postmenopausal women with vaginal bleeding are selected in this cross-sectional study. The uterine bleeding in patients with blood system diseases, reproductive organ outside the uterus, other organs cancer metastasis to the uterus are excluded. The objects are divided into two groups(patients with endometrial benign diseases and patients with endometrial cancer and precancerous diseases) according to endometrial cytological and histological pathology. The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. Moreover,The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which were diagnosed by pathology.
- Conditions
- Endometrial Diseases
- Being tested
- Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium SamplerDiagnostic test
The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which are diagnosed by pathology.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Endometrial Benign Disease Receives: Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler | |
| Group2 | Endometrial Cancer and Precancerous Lesions Receives: Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler |
What is being measured
The primary outcome is the main question the study is designed to answer.
The endometrial vascularization index
The endometrial vascularization index include vascularization index(VI), flow index (FI) and vascularization flow index (VFI).
Measured: From March 2019 to December 2019
Secondary outcomes (3)
The ultrasonography of endometrium
The ultrasonography of endometrium included shape, boundary and echo.
Measured: From March 2019 to December 2019
The endometrial thickness
The endometrial thickness in centimeter.
Measured: From March 2019 to December 2019
The blood flow index of endometrium
The blood flow index include peak systolic velocity(PSV),cm/s, end diastolic velocity(EDV) ,cm/s, mean flow velocity(MnV) ,cm/s, pulsatility index(PI), resistance index(RI).
Measured: From March 2019 to December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start10 Jul 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial DiseasesStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaofeng YANG, Doctor, Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289468
- Sponsor's protocol ID
- XJTU1AF-CRF-2016T-14
- Status last verified
- Sep 2018
- First submitted
- 15 Jun 2017
- Last updated
- 7 Aug 2019
- 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 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases
- ClinicalTrials.gov ID
- NCT03289468
- Acronym / sponsor ID
- XJTU1AF-CRF-2016T-14
- Conditions
- Endometrial Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 21 Sep 2017 (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.
The postmenopausal women with vaginal bleeding were selected in this cross-sectional study. The basic characteristics information and endometrial blood flow energy index of endometrium were detected by color power Doppler ultrasound, and the energy histogram of endometrium was obtained. The specimen of uterine cytology and endometrial tissue were obtained through minimally invasive endometrium sampler, which were diagnosed by pathology. The statistical data were used to detect endometrial and precancerous lesions to observe the endpoint, and to provide the energy histogram model of the early warning endothelial diseases.
Detailed description
The postmenopausal women with vaginal bleeding are selected in this cross-sectional study. The uterine bleeding in patients with blood system diseases, reproductive organ outside the uterus, other organs cancer metastasis to the uterus are excluded. The objects are divided into two groups(patients with endometrial benign diseases and patients with endometrial cancer and precancerous diseases) according to endometrial cytological and histological pathology. The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. Moreover,The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which were diagnosed by pathology.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium SamplerEndometrial Benign Disease |
| Group2 | – | Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium SamplerEndometrial Cancer and Precancerous Lesions |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with vaginal bleeding
Key inclusion criteria (1 listed)
- Postmenopausal women with vaginal bleeding
Key exclusion criteria (2 listed)
- Vaginal bleeding caused by hematological system diseases or genitals outside the uterus
- Uterine bleeding caused by other organ cancers metastasize to the uterus
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 |
|---|---|---|
| Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium SamplerThe endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which are diagnosed by pathology. | Diagnostic test | Group1, Group2 |
Primary outcome
The endometrial vascularization index
Time frame: From March 2019 to December 2019
The endometrial vascularization index include vascularization index(VI), flow index (FI) and vascularization flow index (VFI).
3 secondary outcomes
The ultrasonography of endometrium
Time frame: From March 2019 to December 2019
The endometrial thickness
Time frame: From March 2019 to December 2019
The blood flow index of endometrium
Time frame: From March 2019 to December 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- 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.
Xiaofeng YANG, Doctor study director
First Affiliated Hospital Xi'an Jiaotong University
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 Diseases, run by First Affiliated Hospital Xi'an Jiaotong University 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 2 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 7 Aug 2019. 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?
Contact Xiaofeng YANG, Doctor (0086-18602900810, yxf73@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The endometrial vascularization index (time frame: From March 2019 to December 2019). 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 7 Aug 2019.