A Prospective Cohort Study Of Myasthenia Gravis

NCT04674605 | Unknown

• 1 other identifier: 2020-382
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The average annual incidence of Myasthenia gravis is up to (8.0-20.0) / 100,000 people. Myasthenia gravis is an acquired autoimmune disease. All skeletal muscles of patients may be involved. When ocular muscles are involved, ptosis, diplopia and other symptoms may occur. When the laryngopharyngeal muscles are involved, the patient may develop dysarthria, dysphagia and other symptoms. However, when the respiratory muscles are involved, patients will have difficulty in breathing, and some patients may develope myasthenia crisis, and artificial assisted respiratory therapy is often needed. This study is a prospective observational study, in which patients are continuously enrolled, basic information of patients is collected, and biological samples are collected. The purpose of this study is to improve the diagnosis and prognosis of myasthenia gravis patients.

Conditions

Myasthenia Gravis; Myasthenia Gravis Crisis

Keywords

Myasthenia Gravis; Prognostic prediction

Outcome Measures

Primary Outcomes (1)

• Myasthenia gravis foundation of America post intervention status

  Complete Stable Remission (CSR) Pharmacologic Remission (PR) Minimal Manifestations (MM) Change in Status: Improved (I) Unchanged (U) Worse (W) Exacerbation (E) Died of MG (D of MG)

  3 years

Study Arms (2)

ocular myasthenia gravis

Device: biomarkers

generalized myasthenia gravis

Device: biomarkers

Interventions

biomarkers DEVICE

biomarkers

generalized myasthenia gravis; ocular myasthenia gravis

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese

You may qualify if:

• Meeting the diagnosis of myasthenia gravis

You may not qualify if:

• Malignant tumor or other serious chronic disease

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (2)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, YuZhong District, 400016, China

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Fei Xiao, MD

CONTACT

86 23 89012009; feixiao81@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Fei Xiao

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: December 31, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 30, 2022
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

CN (2)