Kidney DiseaseNCT06363032
Elastography in Predicting Renal Outcome
An observational study of Kidney Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
There are two types of elastography: strain elastography assesses the degree of strain when applying a given amount of force to the skin. Shear-wave elastography assesses the velocity of shear wave propagation within the target lesion. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Disease
- What is being tested?
- elastography
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Dec 2021to 31 Dec 2025
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: patients receiving scheduled renal biopsy and scheduled renal sonography
Who may be able to join
- patients receiving scheduled renal biopsy and scheduled renal sonography
Who cannot join
- age < 20 y/o, patients who can't hold their breath for at least 5 seconds
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Fan-Chi Chang, 886-0223123456, leiny.fc@gmail.com
About this study
Official title: Application of Transthoracic Shear-wave Ultrasound Elastography in the Evaluation of Renal Function and Diagnosis of Renal Disease
There are two types of elastography: strain elastography assesses the degree of strain when applying a given amount of force to the skin. Shear-wave elastography assesses the velocity of shear wave propagation within the target lesion. A part of the tissue is deformed by a "push pulse", the velocity of the shear waves propagating within the tissue is detected, and the stiffness of the tissue is assessed based on the detected shear velocity. Shear-wave elastography has been intensively studied in thyroid, breast, liver, cervical lymph nodes, and musculoskeletal diseases with promising result.
Transthoracic shear-wave ultrasound is also used for the prediction of lung malignancy.
Read more
In progressive renal disease, renal function decline correlates with the extent of interstitial fibrosis, irrespective of the original pathology. Experience and research in using shear-wave elastography to study the stiffness of renal parenchyma and renal fibrosis are scanty. The investigators will conduct a prospective observational study. This study aims to provide the information of tissue elasticity in different etiologies of renal diseases and to validate the predictive value of shear-wave elastography in predicting renal function and renal fibrosis.
By assuming a power of 0.8, a two-side p value of 0.05, a ratio of 0.2 (sample sizes in negative/positive groups) to detect the difference between area under ROC curve and null hypothesis value (0.8 and 0.7), a target sample of 273 (with a 5% cushion, 260~290) patients is required.
- Conditions
- Kidney Disease
- Being tested
- elastography
- Keywords
- elastography
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastographyDiagnostic test
When routine renal ultrasound is arranged, patients will be invited to receive elastography at the same time.
What is being measured
The primary outcome is the main question the study is designed to answer.
collect medical record of blood urea nitrogen and Creatinine
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start27 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363032
- Sponsor's protocol ID
- 202110104RINB
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Transthoracic Shear-wave Ultrasound Elastography in the Evaluation of Renal Function and Diagnosis of Renal Disease
- ClinicalTrials.gov ID
- NCT06363032
- Acronym / sponsor ID
- 202110104RINB
- Conditions
- Kidney Disease
- Keywords
- elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Apr 2024 (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.
There are two types of elastography: strain elastography assesses the degree of strain when applying a given amount of force to the skin. Shear-wave elastography assesses the velocity of shear wave propagation within the target lesion. A part of the tissue is deformed by a "push pulse", the velocity of the shear waves propagating within the tissue is detected, and the stiffness of the tissue is assessed based on the detected shear velocity. Shear-wave elastography has been intensively studied in thyroid, breast, liver, cervical lymph nodes, and musculoskeletal diseases with promising result.
Transthoracic shear-wave ultrasound is also used for the prediction of lung malignancy.
In progressive renal disease, renal function decline correlates with the extent of interstitial fibrosis, irrespective of the original pathology. Experience and research in using shear-wave elastography to study the stiffness of renal parenchyma and renal fibrosis are scanty. The investigators will conduct a prospective observational study. This study aims to provide the information of tissue elasticity in different etiologies of renal diseases and to validate the predictive value of shear-wave elastography in predicting renal function and renal fibrosis.
By assuming a power of 0.8, a two-side p value of 0.05, a ratio of 0.2 (sample sizes in negative/positive groups) to detect the difference between area under ROC curve and null hypothesis value (0.8 and 0.7), a target sample of 273 (with a 5% cushion, 260~290) patients is required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients receiving scheduled renal biopsy and scheduled renal sonography
Key inclusion criteria (1 listed)
- patients receiving scheduled renal biopsy and scheduled renal sonography
Key exclusion criteria (1 listed)
- age < 20 y/o, patients who can't hold their breath for at least 5 seconds
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 |
|---|---|---|
| elastographyWhen routine renal ultrasound is arranged, patients will be invited to receive elastography at the same time. | Diagnostic test | – |
Primary outcome
collect medical record of blood urea nitrogen and Creatinine
Time frame: 3 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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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.
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 Kidney Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collect medical record of blood urea nitrogen and Creatinine (time frame: 3 months and 12 months). 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 12 Apr 2024.