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

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03289468
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 29.7
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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	Phase
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 Design

• Study Type: Observational
• Anticipated 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: Jul 10, 2017
• Anticipated Primary Completion Date: Dec 30, 2019
• Anticipated Study Completion Date: Dec 30, 2019

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. The endometrial vascularization index [From March 2019 to December 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 [From March 2019 to December 2019]

   The ultrasonography of endometrium included shape, boundary and echo.

2. The endometrial thickness [From March 2019 to December 2019]

   The endometrial thickness in centimeter.

3. The blood flow index of endometrium [From March 2019 to December 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061

Sponsors and Collaborators

• First Affiliated Hospital Xi'an Jiaotong University

Investigators

• Study Director: Xiaofeng YANG, Doctor, The First Affiliated Hospital of Xian Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
• ClinicalTrials.gov Identifier: NCT03289468
• Other Study ID Numbers: XJTU1AF-CRF-2016T-14
• First Posted: Sep 21, 2017
• Last Update Posted: Aug 7, 2019
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Aug 7, 2019