Identifying Ultrasonic Diagnostic Characteristics of Cervical Lymphadenopathy: A Retrospective, Multicenter Study

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Completed

CT.gov ID

NCT04497714

Collaborator

(none)

500

Enrollment

Location

Actual Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The observed indexes of the four cervical lymph node diseases were identified by informatics methods, and the differences in the diagnosis of the four diseases were evaluated, so as to improve the clinical diagnosis rate and provide a research basis for the ultrasonic evaluation of the surgical indications of cervical lymph node diseases in the future.

Condition or Disease	Intervention/Treatment	Phase
Lymph Node Disease Ultrasound Therapy; Complications	Diagnostic Test: Ultrasonic image collection

Study Design

Study Type:

Observational

Actual Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Identifying Ultrasonic Diagnostic Characteristics of Cervical Lymphadenopathy: A Retrospective, Multicenter Study

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Cervical lymph nodes tuberculosis The patients with Cervical lymph nodes tuberculosis	Diagnostic Test: Ultrasonic image collection Ultrasonic image collection,consist of three static images and one dynamic image
Cervical lymphoma The patients with	Diagnostic Test: Ultrasonic image collection Ultrasonic image collection,consist of three static images and one dynamic image
Cervical lymph node metastasis The patients with	Diagnostic Test: Ultrasonic image collection Ultrasonic image collection,consist of three static images and one dynamic image
Cervical Reactive hyperplasia The patients with	Diagnostic Test: Ultrasonic image collection Ultrasonic image collection,consist of three static images and one dynamic image

Outcome Measures

Primary Outcome Measures

Cervical lymph nodes tuberculosis [through study completion, an average of 1 year]
It was identified as cervical lymph node tuberculosis by imaging observation
Cervical lymphoma [through study completion, an average of 1 year]
It was identified as cervical lymphoma by imaging observation
Cervical lymph node metastasis [through study completion, an average of 1 year]
It was identified as Cervical lymph node metastasis by imaging observation
Cervical Reactive hyperplasia [through study completion, an average of 1 year]
It was identified as Cervical Reactive hyperplasia by imaging observation

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with one of these four diseases

Exclusion Criteria:

1. Patients with severe heart and brain diseases and poor coagulation function. 2. Undiagnosed patients are not included in the statistical analysis. 3. Image distortion of CEUS acquisition cannot be analyzed.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	0571

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04497714

Other Study ID Numbers:

研2020-539

First Posted:

Aug 4, 2020

Last Update Posted:

Aug 4, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphadenopathy

Study Results

No Results Posted as of Aug 4, 2020