Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2017
CompletedStudy Start
First participant enrolled
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
September 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedAugust 7, 2019
September 1, 2018
2.5 years
June 15, 2017
August 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The endometrial vascularization index
The endometrial vascularization index include vascularization index(VI), flow index (FI) and vascularization flow index (VFI).
From March 2019 to December 2019
Secondary Outcomes (3)
The ultrasonography of endometrium
From March 2019 to December 2019
The endometrial thickness
From March 2019 to December 2019
The blood flow index of endometrium
From March 2019 to December 2019
Study Arms (2)
Group1
Endometrial Benign Disease
Group2
Endometrial Cancer and Precancerous Lesions
Interventions
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.
Eligibility Criteria
Postmenopausal women with vaginal bleeding
You may qualify if:
- Postmenopausal women with vaginal bleeding
You may not qualify if:
- Vaginal bleeding caused by hematological system diseases or genitals outside the uterus
- Uterine bleeding caused by other organ cancers metastasize to the uterus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Biospecimen
FirstXianJiaotongU
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xiaofeng YANG, Doctor
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2017
First Posted
September 21, 2017
Study Start
July 10, 2017
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
August 7, 2019
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share