Clincosm LogoSign in Get a demo

A Registered Cohort Study of Immune-Mediated Neuropathies

Sponsor
First Affiliated Hospital of Fujian Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04292834
Collaborator
Beijing Tiantan Hospital (Other)
1,000
Enrollment
2
Locations
58.7
Anticipated Duration (Months)
500
Patients Per Site
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Registered Cohort Study of Immune-Mediated Neuropathies
    Actual Study Start Date :
    Feb 29, 2020
    Anticipated Primary Completion Date :
    Jan 19, 2022
    Anticipated Study Completion Date :
    Jan 19, 2025

    Outcome Measures

    Primary Outcome Measures

    1. The correlation between clinical phenotypes and Serum antibodies [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.
    1. Age 18 or above
    Exclusion Criteria:

    1. Severe complications

    2. Poor prognosis (<1 year survival)

    3. Severe mental disorder and inability to cooperate with the examination.

    4. Age less than 18

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tiantan Hospital, Capital Medical University Beijing Beijing China
    2 Department of Neurology,First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 350005

    Sponsors and Collaborators

    • First Affiliated Hospital of Fujian Medical University
    • Beijing Tiantan Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ning Wang, MD., PhD., Director, First Affiliated Hospital of Fujian Medical University
    ClinicalTrials.gov Identifier:
    NCT04292834
    Other Study ID Numbers:
    • MRCTA，ECFAH of FMU2019217
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    Dec 30, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Polyneuropathies
    Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

    Study Results

    No Results Posted as of Dec 30, 2021