NCT04292834

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2025

Completed
Last Updated

December 30, 2021

Status Verified

December 1, 2021

Enrollment Period

1.9 years

First QC Date

February 28, 2020

Last Update Submit

December 28, 2021

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Outcome Measures

Primary Outcomes (1)

  • 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.

    from date of enrollment until the date of death from any cause,assessed up to 20 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • \- 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.
  • \. Age 18 or above

You may not qualify if:

  • Severe complications
  • Poor prognosis (\<1 year survival)
  • Severe mental disorder and inability to cooperate with the examination.
  • Age less than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Department of Neurology,First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

NOT YET RECRUITING

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Lin Yi, PhD

CONTACT

86-0591-87982772linyi7811@163.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 3, 2020

Study Start

February 29, 2020

Primary Completion

January 19, 2022

Study Completion

January 19, 2025

Last Updated

December 30, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)