- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292834
A Registered Cohort Study of Immune-Mediated Neuropathies
December 28, 2021 updated by: Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University
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 Overview
Status
Recruiting
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lin Yi, PhD
- Phone Number: 86-0591-87982772
- Email: linyi7811@163.edu
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Beijing Tiantan Hospital, Capital Medical University
-
Contact:
- Zaiqiang Zhang
-
Principal Investigator:
- Zaiqiang Zhang, PhD
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- Not yet recruiting
- Department of Neurology,First Affiliated Hospital of Fujian Medical University
-
Principal Investigator:
- Wang MD Ning, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Severe complications
- Poor prognosis (<1 year survival)
- Severe mental disorder and inability to cooperate with the examination.
- Age less than 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
from date of enrollment until the date of death from any cause,assessed up to 20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 29, 2020
Primary Completion (Anticipated)
January 19, 2022
Study Completion (Anticipated)
January 19, 2025
Study Registration Dates
First Submitted
February 28, 2020
First Submitted That Met QC Criteria
February 28, 2020
First Posted (Actual)
March 3, 2020
Study Record Updates
Last Update Posted (Actual)
December 30, 2021
Last Update Submitted That Met QC Criteria
December 28, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRCTA,ECFAH of FMU2019217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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