Chronic Inflammatory Demyelinating PolyneuropathyNCT04292834
A Registered Cohort Study of Immune-Mediated Neuropathies
An observational study of Chronic Inflammatory Demyelinating Polyneuropathy, run by First Affiliated Hospital of Fujian Medical University at 2 sites in China.
Trial summary
This study will provide further insights into the natural course of the disease about Immune-Mediated Neuropathies including clinical features，progression, related antibody spectrum and drug treatment effect. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 29 Feb 2020to 19 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with GBS,CIDP,MMN who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy and Beijing Tiantan Hospital, Capital Medical University by two neurolgists
Who may be able to join
- 1. Outpatient or inpatient 2. Meet the diagnostic criteria of various inflammatory peripheral neuropathy. 3. Voluntary participation and informed consent signed by the applicant or his/her family.
- 4. Age 18 or above
Who cannot join
- Severe complications
- Poor prognosis (<1 year survival)
- Severe mental disorder and inability to cooperate with the examination.
- Age less than 18
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Zaiqiang Zhang
Zaiqiang Zhang, PhD
- Not yet recruiting
Department of Neurology,First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Wang Ning, PhD, 86-0591-87982772, ningwang@fjmu.edu.cn
Wang MD Ning, PhD
About this study
This study will provide further insights into the natural course of the disease about Immune-Mediated Neuropathies including clinical features，progression, related antibody spectrum and drug treatment effect.
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between clinical phenotypes and Serum antibodies
Different clinical subtypes of GBS and CIDP have different course and prognosis.It may be related to different serum antibodies.
Measured: from date of enrollment until the date of death from any cause,assessed up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start29 Feb 2020
- Primary completion19 Jan 2022 (estimated)
- Study completion19 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292834
- Sponsor's protocol ID
- MRCTA，ECFAH of FMU2019217
- Status last verified
- Dec 2021
- First submitted
- 28 Feb 2020
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registered Cohort Study of Immune-Mediated Neuropathies
- ClinicalTrials.gov ID
- NCT04292834
- Acronym / sponsor ID
- MRCTA，ECFAH of FMU2019217
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 29 Feb 2020 (actual)
- Primary completion
- 19 Jan 2022 (estimated)
- Study completion
- 19 Jan 2025 (estimated)
- First posted
- 3 Mar 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.
This study will provide further insights into the natural course of the disease about Immune-Mediated Neuropathies including clinical features，progression, related antibody spectrum and drug treatment effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with GBS,CIDP,MMN who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy and Beijing Tiantan Hospital, Capital Medical University by two neurolgists
Key inclusion criteria (2 listed)
- 1. Outpatient or inpatient 2. Meet the diagnostic criteria of various inflammatory peripheral neuropathy. 3. Voluntary participation and informed consent signed by the applicant or his/her family.
- 4. Age 18 or above
Key exclusion criteria (4 listed)
- Severe complications
- Poor prognosis (<1 year survival)
- Severe mental disorder and inability to cooperate with the examination.
- Age less than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation between clinical phenotypes and Serum antibodies
Time frame: from date of enrollment until the date of death from any cause,assessed up to 20 years
Different clinical subtypes of GBS and CIDP have different course and prognosis.It may be related to different serum antibodies.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Demyelinating Polyneuropathy, run by First Affiliated Hospital of Fujian Medical University at 2 sites 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 2 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 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Lin Yi, PhD (86-0591-87982772, linyi7811@163.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between clinical phenotypes and Serum antibodies (time frame: from date of enrollment until the date of death from any cause,assessed up to 20 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 30 Dec 2021.