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

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ClinicalTrials.gov Identifier: NCT03289468
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment
Endometrial Diseases Diagnostic Test: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler

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 Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : December 30, 2017

Group/Cohort Intervention/treatment
Group1
Endometrial Benign Disease
Diagnostic Test: Voluson 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.

Group2
Endometrial Cancer and Precancerous Lesions
Diagnostic Test: Voluson 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.




Primary Outcome Measures :
  1. The endometrial vascularization index [ Time Frame: From June 2017 to March 2019 ]
    The endometrial vascularization index include vascularization index(VI), flow index (FI) and vascularization flow index (VFI).


Secondary Outcome Measures :
  1. The ultrasonography of endometrium [ Time Frame: From June 2017 to March 2019 ]
    The ultrasonography of endometrium included shape, boundary and echo.

  2. The endometrial thickness [ Time Frame: From June 2017 to March 2019 ]
    The endometrial thickness in centimeter.

  3. The blood flow index of endometrium [ Time Frame: From June 2017 to March 2019 ]
    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).


Biospecimen Retention:   Samples Without DNA
FirstXianJiaotongU


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Postmenopausal women with vaginal bleeding
Criteria

Inclusion Criteria:

  • Postmenopausal women with vaginal bleeding

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289468


Contacts
Contact: Xiaofeng YANG, Doctor 0086-18602900810 yxf73@163.com

Locations
China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Xiaofeng YANG       yxf73@163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
Study Director: Xiaofeng YANG, Doctor Deputy Director of Obstetrics and Gynecology of First Affiliated Hospital of Xian Jiaotong University

Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03289468     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2016T-14
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female