ClinicalTrials.gg
Status unknownNCT03289468Updated Aug 7, 2019

Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases

An observational study in Endometrial Diseases, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to female participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-07.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
200
Ages
45 Years to 80 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Endometrial Diseases

Browse trials for

03

In context

Uterine Diseases

73 studies on the registry are indexed under Uterine Diseases; 9 are open to participants now.

This study's planned enrollment of 200 is above the median of 135 across 13 observational studies indexed under Uterine Diseases.

Browse Uterine Diseases studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Postmenopausal women with vaginal bleeding

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women with vaginal bleeding

Exclusion criteria

Exclusion Criteria:

  • Vaginal bleeding caused by hematological system diseases or genitals outside the uterus
  • Uterine bleeding caused by other organ cancers metastasize to the uterus
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group1

    Endometrial Benign Disease

    Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler

  • Group2

    Endometrial Cancer and Precancerous Lesions

    Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler

Interventions

  • Diagnostic testVoluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler

    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.

06

What researchers measure

Primary outcomes

  1. The endometrial vascularization index

    The endometrial vascularization index include vascularization index(VI), flow index (FI) and vascularization flow index (VFI).

    Time frame: From March 2019 to December 2019

Secondary outcomes

  1. The ultrasonography of endometrium

    The ultrasonography of endometrium included shape, boundary and echo.

    Time frame: From March 2019 to December 2019

  2. The endometrial thickness

    The endometrial thickness in centimeter.

    Time frame: From March 2019 to December 2019

  3. 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).

    Time frame: From March 2019 to December 2019

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2017 (actual). Primary completion is estimated for Dec 2019, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2017
First posted
Sep 21, 2017
StartActual
Jul 10, 2017
Primary completionEst.
Dec 30, 2019
CompletionEst.
Dec 30, 2019
Last update
Aug 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03289468
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Jul 10, 2017
Primary completion
Dec 30, 2019 (estimated)
Completion
Dec 30, 2019 (estimated)
Last update
Aug 7, 2019

Study contacts

Xiaofeng YANG, Doctor
Contact
yxf73@163.com
0086-18602900810
Xiaofeng YANG, Doctor
study director · The First Affiliated Hospital of Xian Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion