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

August 2, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 0571
        • Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with one of these four diseases

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical lymph nodes tuberculosis
Time Frame: through study completion, an average of 1 year
It was identified as cervical lymph node tuberculosis by imaging observation
through study completion, an average of 1 year
Cervical lymphoma
Time Frame: through study completion, an average of 1 year
It was identified as cervical lymphoma by imaging observation
through study completion, an average of 1 year
Cervical lymph node metastasis
Time Frame: through study completion, an average of 1 year
It was identified as Cervical lymph node metastasis by imaging observation
through study completion, an average of 1 year
Cervical Reactive hyperplasia
Time Frame: through study completion, an average of 1 year
It was identified as Cervical Reactive hyperplasia by imaging observation
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

January 1, 2020

Study Completion (ACTUAL)

January 1, 2020

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

August 2, 2020

First Posted (ACTUAL)

August 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 2, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 研2020-539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

individual participant data(IPD) can be shared after the main unit publish articles

IPD Sharing Time Frame

by request

IPD Sharing Access Criteria

by request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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