- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792931
Adult Autoimmune Myopathies (MAIA) (MAIA)
May 20, 2022 updated by: University Hospital, Brest
Adult Autoimmune Myopathies (MAIA): Clinical and Immunological Characterization, Constitution of a Patient Library
This study corresponds to a monocentric prospective cohort of adult patients presenting a suspicion of idiopathic inflammatory myopathy.
It will allows the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood sample, urine, stool and muscle specimen.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
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: Dewi GUELLEC
- Phone Number: 0230337617
- Email: dewi.guellec@chu-brest.fr
Study Locations
-
-
-
Brest, France, 29200
- Recruiting
- CHU de Brest
-
Contact:
- Dewi GUELLEC
- Phone Number: 0230337617
- Email: dewi.guellec@chu-brest.fr
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical suspicion of Adult Inflammatory Myopathy
- Social security affiliation
Exclusion Criteria:
- Pregnant and lactating women
- Patients unable to consent
- Patients refusing to participate in the research.
- Patients under legal protection
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Adult Autoimmune Myopathies
It is a description Autoimmune Myopathie cohort
|
description of adult autoimmune myopathies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distribution of lymphocytes subpopulations (B, T and TH-17)
Time Frame: 6 months
|
Distribution of lymphocytes subpopulations (B, T and TH-17) according to the final diagnosis defined by a panel of experts
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 20, 2022
Primary Completion (Anticipated)
May 20, 2030
Study Completion (Anticipated)
May 20, 2030
Study Registration Dates
First Submitted
March 8, 2021
First Submitted That Met QC Criteria
March 10, 2021
First Posted (Actual)
March 11, 2021
Study Record Updates
Last Update Posted (Actual)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 20, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC20.0276
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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