ImmunosuppressionHLA-DRNCT04360772
Monitoring of Corticosteroids Induced Immunosuppression Using Monocyte Human Leukocyte Antigen-DR (mHLA-DR).
An observational study of Immunosuppression, run by Hospices Civils de Lyon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunosuppression
- What is being tested?
- mHLA-DR
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient Diagnosed With Any Pathology Indicating a Treatment by Corticotherapy
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Monitoring of Corticosteroids Induced Immunosuppression Using mHLA-DR
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
- Being tested
- mHLA-DR
- Keywords
- any pathology, corticosteroids therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHLA-DRDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 1, 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Why it stopped: project cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ARNAUD HOT, MD, Principal investigator, Service de Médecine Interne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360772
- Sponsor's protocol ID
- 69HCL19_1029
- Acronym
- HLA-DR
- Status last verified
- Feb 2024
- First submitted
- 15 Apr 2020
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Corticosteroids Induced Immunosuppression Using mHLA-DR
- ClinicalTrials.gov ID
- NCT04360772
- Acronym / sponsor ID
- HLA-DR / 69HCL19_1029
- Conditions
- Immunosuppression
- Keywords
- any pathology, corticosteroids therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: project cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient Diagnosed With Any Pathology Indicating a Treatment by Corticotherapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Treatment by corticosteroids in the previous 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
Kinetics of mHLA-DR expression determined by flow cytometry before treatment and during the 6 first months of degressive corticosteroids doses
Time frame: Month 1, 3 and 6
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ARNAUD HOT, MD principal investigator
Service de Médecine Interne
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppression, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetics of mHLA-DR expression determined by flow cytometry before treatment and during the 6 first months of degressive corticosteroids doses (time frame: Month 1, 3 and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.