Lymph Node DiseaseNCT04497714
Identifying Ultrasonic Diagnostic Characteristics of Cervical Lymphadenopathy: A Retrospective, Multicenter Study
An observational study of Lymph Node Disease and Ultrasound Therapy; Complications, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymph Node Disease, Ultrasound Therapy; Complications
- What is being tested?
- Ultrasonic image collection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with one of these four diseases
Who may be able to join
- Patients with one of these four diseases
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 0571
About this study
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.
- Being tested
- Ultrasonic image collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic image collectionDiagnostic test
Ultrasonic image collection,consist of three static images and one dynamic image
| Study group | Role | What they receive |
|---|---|---|
| Cervical lymph nodes tuberculosis | The patients with Cervical lymph nodes tuberculosis Receives: Diagnostic Test: Ultrasonic image collection | |
| Cervical lymphoma | The patients with Receives: Diagnostic Test: Ultrasonic image collection | |
| Cervical lymph node metastasis | The patients with Receives: Diagnostic Test: Ultrasonic image collection | |
| Cervical Reactive hyperplasia | The patients with Receives: Diagnostic Test: Ultrasonic image collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical lymph nodes tuberculosis
It was identified as cervical lymph node tuberculosis by imaging observation
Measured: through study completion, an average of 1 year
Cervical lymphoma
It was identified as cervical lymphoma by imaging observation
Measured: through study completion, an average of 1 year
Cervical lymph node metastasis
It was identified as Cervical lymph node metastasis by imaging observation
Measured: through study completion, an average of 1 year
Cervical Reactive hyperplasia
It was identified as Cervical Reactive hyperplasia by imaging observation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497714
- Sponsor's protocol ID
- 研2020-539
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data(IPD) can be shared after the main unit publish articles
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Ultrasonic Diagnostic Characteristics of Cervical Lymphadenopathy: A Retrospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT04497714
- Acronym / sponsor ID
- 研2020-539
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cervical lymph nodes tuberculosis | – | Diagnostic Test: Ultrasonic image collectionThe patients with Cervical lymph nodes tuberculosis |
| Cervical lymphoma | – | Diagnostic Test: Ultrasonic image collectionThe patients with |
| Cervical lymph node metastasis | – | Diagnostic Test: Ultrasonic image collectionThe patients with |
| Cervical Reactive hyperplasia | – | Diagnostic Test: Ultrasonic image collectionThe patients with |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with one of these four diseases
Key inclusion criteria (1 listed)
- Patients with one of these four diseases
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic image collectionUltrasonic image collection,consist of three static images and one dynamic image | Diagnostic test | Cervical Reactive hyperplasia, Cervical lymph node metastasis, Cervical lymph nodes tuberculosis, Cervical lymphoma |
Primary outcome
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
Cervical lymphoma
Time frame: through study completion, an average of 1 year
It was identified as cervical lymphoma by imaging observation
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
Cervical Reactive hyperplasia
Time frame: through study completion, an average of 1 year
It was identified as Cervical Reactive hyperplasia by imaging observation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: Yes. individual participant data(IPD) can be shared after the main unit publish articles
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymph Node Disease and Ultrasound Therapy; Complications, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical lymph nodes tuberculosis (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.