Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738824
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2023-02-18
Brief Title:
Natural History of Inflammatory Muscle Diseases
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History of Inflammatory Muscle Diseases
Status:
RECRUITING
Status Verified Date:
2024-01-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective
To collect information and biospecimens such as blood muscle and skin samples that will be used to research causes and treatments of inflammatory muscle diseases
Eligibility
People aged 12 years and older with suspected or confirmed inflammatory muscle disease Healthy volunteers aged 18 years and older are also needed
Design
Participants will have at least 1 clinic visit Each visit will last 4 to 8 hours Some may return for additional visits
All participants will undergo these procedures unless they are unable to
Physical exam including blood and urine tests
Magnetic resonance imaging MRI scan of the thigh Participants will lie still on a table with padding around 1 thigh The table will slide into a tube The scan will last for approximately 40 minutes
Some procedures are optional
Muscle biopsy An area of skin will be numbed A quarter-inch cut will be made Several pieces of muscle tissue about the size of grains of rice will be removed
Skin biopsy An area of skin will be numbed A piece of skin about a quarter inch in diameter will be removed
Genetic testing Some of the samples collected may be used for genetic testing
To collect information and biospecimens such as blood muscle and skin samples that will be used to research causes and treatments of inflammatory muscle diseases
Eligibility
People aged 12 years and older with suspected or confirmed inflammatory muscle disease Healthy volunteers aged 18 years and older are also needed
Design
Participants will have at least 1 clinic visit Each visit will last 4 to 8 hours Some may return for additional visits
All participants will undergo these procedures unless they are unable to
Physical exam including blood and urine tests
Magnetic resonance imaging MRI scan of the thigh Participants will lie still on a table with padding around 1 thigh The table will slide into a tube The scan will last for approximately 40 minutes
Some procedures are optional
Muscle biopsy An area of skin will be numbed A quarter-inch cut will be made Several pieces of muscle tissue about the size of grains of rice will be removed
Skin biopsy An area of skin will be numbed A piece of skin about a quarter inch in diameter will be removed
Genetic testing Some of the samples collected may be used for genetic testing
Detailed Description:
Study Description
This is an observational study to characterize the different types of inflammatory myopathies understand their etiology pathogenesis prognosis and response to different treatments
Objectives
Primary objective Define the different types of inflammatory muscle diseases their etiology pathogenesis prognostic factors and response to different treatments
Secondary objectives Study different diagnostic modalities that may help to diagnose and monitor the evolution of the disease in patients with myositis
Endpoints
Primary endpoint Severity of muscle skin pulmonary and joint involvement Study of the immune dysregulation transcriptomic changes and genetic modifications in patients with inflammatory muscle diseases
Secondary endpoints Utility of standard of care laboratory radiologic electrophysiologic and clinical studies to diagnose and monitor the evolution of the disease in patients with myositis
This is an observational study to characterize the different types of inflammatory myopathies understand their etiology pathogenesis prognosis and response to different treatments
Objectives
Primary objective Define the different types of inflammatory muscle diseases their etiology pathogenesis prognostic factors and response to different treatments
Secondary objectives Study different diagnostic modalities that may help to diagnose and monitor the evolution of the disease in patients with myositis
Endpoints
Primary endpoint Severity of muscle skin pulmonary and joint involvement Study of the immune dysregulation transcriptomic changes and genetic modifications in patients with inflammatory muscle diseases
Secondary endpoints Utility of standard of care laboratory radiologic electrophysiologic and clinical studies to diagnose and monitor the evolution of the disease in patients with myositis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000894-AR | None | None | None |