NCT04497714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

July 27, 2020

Last Update Submit

August 2, 2020

Conditions

Lymph Node DiseaseUltrasound Therapy; Complications

Outcome Measures

Primary Outcomes (4)

  • Cervical lymph nodes tuberculosis

    It was identified as cervical lymph node tuberculosis by imaging observation

    through study completion, an average of 1 year

  • Cervical lymphoma

    It was identified as cervical lymphoma by imaging observation

    through study completion, an average of 1 year

  • Cervical lymph node metastasis

    It was identified as Cervical lymph node metastasis by imaging observation

    through study completion, an average of 1 year

  • Cervical Reactive hyperplasia

    It was identified as Cervical Reactive hyperplasia by imaging observation

    through study completion, an average of 1 year

Study Arms (4)

Cervical lymph nodes tuberculosis

The patients with Cervical lymph nodes tuberculosis

Diagnostic Test: Ultrasonic image collection

Cervical lymphoma

The patients with

Diagnostic Test: Ultrasonic image collection

Cervical lymph node metastasis

The patients with

Diagnostic Test: Ultrasonic image collection

Cervical Reactive hyperplasia

The patients with

Diagnostic Test: Ultrasonic image collection

Interventions

Ultrasonic image collectionDIAGNOSTIC_TEST

Ultrasonic image collection,consist of three static images and one dynamic image

Cervical Reactive hyperplasiaCervical lymph node metastasisCervical lymph nodes tuberculosisCervical lymphoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with one of these four diseases

You may qualify if:

  • Patients with one of these four diseases

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 0571, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2020

First Posted

August 4, 2020

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

August 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
by request
Access Criteria
by request

Locations

CN(1)