ANCA Associated VasculitisNCT04923074
the Application of Diffusion Tensor Imaging in the Evaluation of Peripheral Neuropathy in ANCA Associated Vasculitis
An observational study of ANCA Associated Vasculitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
1. Include qualified 50 ANCA-associated vasculitis(AAV) patients; and the first 27 patients will be divided into 3 groups with different diffused tension image (DTI) parameters and to choose the best strategy； 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ANCA Associated Vasculitis
- What is being tested?
- diffusion tensor imaging(DTI) evaluation
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jul 2021to Jul 2023
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: adult AAV patients with peripheral neuropathy
Who may be able to join
- age between 18-80 years old；
- must fulfill 2012 criteria of ANCA associated vasculitis
- presented with peripheral neuropathy diagnosed by specialists
Who cannot join
- the ANCA associated vasculitis is already in the stable stage after treatments
- any vital organ dysfunction
- active infection or cancer
- can not finish DTI scan
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd affiliated hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310000
wenjia sun, 86 15869029727, sunwinjoy@zju.edu.cn
About this study
Official title: the Application of Diffusion Tensor Imaging(DTI) in the Evaluation of Peripheral Neuropathy in Anti-neutrophil Cytoplasmic Antibodies Associated Vasculitis(AAV)
- Include qualified 50 ANCA-associated vasculitis(AAV) patients; and the first 27 patients will be divided into 3 groups with different diffused tension image (DTI) parameters and to choose the best strategy；
- On baseline, 6 months after treatment and 24 months after treatment, the AAV patients will accomplish the Birming-ham vasculitis activity score(BVAS) besides DTI；
- The new serum biomarkers of AAV associated peripheral neuropathy will be measured by ELISA； (4) Another cohort with 50 patients with AAV associated peripheral neuropathy who were evaluated by traditional methods (electromyogram) and compared to the patients cohort that evaluated using DTI by cost-benefit analysis
- Conditions
- ANCA Associated Vasculitis
- Being tested
- diffusion tensor imaging(DTI) evaluation
- Keywords
- peripheral neuropathy
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion tensor imaging(DTI) evaluationOther
DTI is a new kind of MRI technique to evaluate peripheral neuropathy
| Study group | Role | What they receive |
|---|---|---|
| DTI group | the patient in this group will receive DTI evaluation Receives: Other: diffusion tensor imaging(DTI) evaluation | |
| routine group | the patient in this group will receive routine evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the optimal b-value (a key parameter) for DTI in AAV associated peripheral neuropathy
b-value is a key technique parameter for DTI, which will decide the quality of DTI image
Measured: 2 years
Secondary outcomes (2)
the association between normative diffusion value of DTI (FA and ADC value) and disease activity activity score of AAV (BVAS).
Birmingham Vasculitis Activity Score (BVAS) is a index of vasculitis disease activity, with the score range 0-63. Fractional anisotropy(FA) and apparent diffusion coefficient(ADC) are two parameters that can be read through DTI image .
Measured: 2 years
the association between normative diffusion value of DTI (FA and ADC value) and serum biomarkers of AAV associated neuropathy
sCD163, Nfl（neurofilament light polypeptide）and OPN（osteopontin）are new biomarkers of peripheral neuropathy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study startJul 2021 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA Associated VasculitisStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Xue, Study chair, 2nd affiliated hospital of Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923074
- Sponsor's protocol ID
- 2020-162
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Application of Diffusion Tensor Imaging(DTI) in the Evaluation of Peripheral Neuropathy in Anti-neutrophil Cytoplasmic Antibodies Associated Vasculitis(AAV)
- ClinicalTrials.gov ID
- NCT04923074
- Acronym / sponsor ID
- 2020-162
- Conditions
- ANCA Associated Vasculitis
- Keywords
- peripheral neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 11 Jun 2021 (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.
- Include qualified 50 ANCA-associated vasculitis(AAV) patients; and the first 27 patients will be divided into 3 groups with different diffused tension image (DTI) parameters and to choose the best strategy；
- On baseline, 6 months after treatment and 24 months after treatment, the AAV patients will accomplish the Birming-ham vasculitis activity score(BVAS) besides DTI；
- The new serum biomarkers of AAV associated peripheral neuropathy will be measured by ELISA； (4) Another cohort with 50 patients with AAV associated peripheral neuropathy who were evaluated by traditional methods (electromyogram) and compared to the patients cohort that evaluated using DTI by cost-benefit analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DTI group | – | Other: diffusion tensor imaging(DTI) evaluationthe patient in this group will receive DTI evaluation |
| routine group | – | –the patient in this group will receive routine evaluation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult AAV patients with peripheral neuropathy
Key inclusion criteria (3 listed)
- age between 18-80 years old；
- must fulfill 2012 criteria of ANCA associated vasculitis
- presented with peripheral neuropathy diagnosed by specialists
Key exclusion criteria (4 listed)
- the ANCA associated vasculitis is already in the stable stage after treatments
- any vital organ dysfunction
- active infection or cancer
- can not finish DTI scan
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 |
|---|---|---|
| diffusion tensor imaging(DTI) evaluationDTI is a new kind of MRI technique to evaluate peripheral neuropathy | Other | DTI group |
Primary outcome
To assess the optimal b-value (a key parameter) for DTI in AAV associated peripheral neuropathy
Time frame: 2 years
b-value is a key technique parameter for DTI, which will decide the quality of DTI image
2 secondary outcomes
the association between normative diffusion value of DTI (FA and ADC value) and disease activity activity score of AAV (BVAS).
Time frame: 2 years
the association between normative diffusion value of DTI (FA and ADC value) and serum biomarkers of AAV associated neuropathy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
Related trials for ANCA Associated Vasculitis
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Recruiting
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Systemic Lupus Erythematosus, Systemic Sclerosis
RecruitingPhase 1
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
RecruitingPhase 1
A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
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.
Jing Xue study chair
2nd affiliated hospital of Zhejiang University, School of Medicine
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 ANCA Associated Vasculitis, 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 3 inclusion and 4 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 11 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wenjia sun (86 15869029727, sunwinjoy@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the optimal b-value (a key parameter) for DTI in AAV associated peripheral neuropathy (time frame: 2 years). 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 11 Jun 2021.