Monitoring of Corticosteroids Induced Immunosuppression Using Monocyte Human Leukocyte Antigen-DR (mHLA-DR).

Immunosuppression Clinical Trial

— HLA-DR  

Official title:

Monitoring of Corticosteroids Induced Immunosuppression Using mHLA-DR

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04360772
• Other study ID #: 69HCL19_1029
• Status: Withdrawn
• Start date: January 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Corticotherapy is widely used in auto-immune diseases. If induced immunosuppression by corticosteroids is well admitted, it's currently not possible to determine individual risk of infection. Thus, the development of new biomarkers able to reflect immunological status under immunosuppressive treatments is needed. It would help identifying patients who would benefit from adapted treatment protocols or infectious prophylaxis. In this field, the mHLA-DR (monocyte Human Leukocyte Antigen-DR) has shown encouraging results. However, it has never been used in patients treated by immunosuppressive therapies. The investigators aim to describe changes induced by corticosteroids in mHLA-DR expression in vivo. To achieve this goal, the investigators will measure mHLA-DR before treatment, after 1 months, 3 months and 6 months of treatment. Finally, the investigators will look for correlation between the level of expression of mHLA-DR and the cumulated dose of corticosteroids administered.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient aged of 18 years old or more, male or female.

• Patient diagnosed with any pathology indicating a treatment by corticotherapy at 1mg/kg/day.

• Patient who didn't express any opposition to be enrolled in the study after reading the dedicated information letter.

• Patient affiliated to social heath care regimen

Exclusion Criteria:

• Treatment by corticosteroids in the previous 6 months.

• Immunsuppressive treatment (except for corticosteroids) in the previous 2 years.

• Patient under judicial protection, guardianship or curators

Related Conditions & MeSH terms

• Immunosuppression

Intervention

Diagnostic Test:
• mHLA-DR
Before treatment/ At inclusion/Day 0 : Collection of gender, date of birth, comorbidities, pathology implicating treatment by corticosteroids and other treatment administered at the time of inclusion. At Day 0, Month 1, Month 3, Month 6 : Blood sampling (3mL) to proceed to mHLA-DR measurement. At those time-points, results from lymphocytes immunophenotyping, C-reactive protein and numeration will be collected. At Month 24 : Collection from medical report of any infectious events that would have occured during the follow-up course of the disease with corticosteroids survival or death at 24 months of follow-up.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetics of mHLA-DR expression determined by flow cytometry before treatment and during the 6 first months of degressive corticosteroids doses	mHLA-DR expression level will be compared between : Before treatment and at 1 month of treatment; Before treatment and at 3 months of treatment; Before treatment and at 6 months of treatment; 1 month and 3 months of treatment; 1 month and 6 months of treatment	Month 1, 3 and 6