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

NCT04360772 | Withdrawn

• 1 other identifier: 69HCL19_1029
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Immunosuppression

Keywords

any pathology; corticosteroids therapy

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

mHLA-DR DIAGNOSTIC_TEST

* 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient Diagnosed With Any Pathology Indicating a Treatment by Corticotherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Officials

• ARNAUD HOT, MD

  Service de Médecine Interne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 24, 2020
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02