Immune SystemSENIOR HLA DRNCT06513520
Evaluation of Monocyte Expression of HLA-DR (mHLA-DR) in Geriatric Service
An observational study of Immune System, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
The acceleration of population aging and the improved management of comorbidities lead to an increase in the number of multi-pathological elderly patients admitted to geriatric services. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Immune System
- What is being tested?
- Blood sampling
- How many people
- 81 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Jan 2025to 23 Jun 2025
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This study will focus on polypathological patients aged over 75 hospitalised in a geriatric ward.
Who may be able to join
- For all patients:
- Patients aged over 75 hospitalised in one of the geriatric units defined as the research sites;
- Patient affiliated to a social security scheme;
- Patients or relatives who have been informed and have no objections to the research.
- To be eligible in the acute situation sub-population:
- Patients presenting with an acute episode on admission or following a stay in the research sites; The acute episode is defined, for example, by an infection, cardiac decompensation, a complicated fall, acute renal failure, any acute or decompensated cardiovascular pathology, any discovery of cancer that has not been stabilised.
- To be eligible in the stable situation sub-population:
- A patient who has not had an acute episode for at least 7 days.
Who cannot join
- For all patients:
- Patients under legal protection: curatorship, guardianship, safeguard of justice ;
- Patients under exclusive comfort care for whom it has been decided not to take a blood sample;
- Patients undergoing long-term antibiotic treatment, i.e. with no defined stopping date;
- An immunocompromised patient or a patient undergoing immunosuppressive treatment (for example: HIV infection, a patient awaiting solid organ transplantation, a patient undergoing haematopoietic stem cell transplantation, a patient undergoing chemotherapy for a solid tumour or haematological malignancy, a patient suffering from an auto-immune disease and being treated with immunotherapy and/or immunosuppressive therapy and/or biotherapy, an asplenic or hyposplenic patient, a patient undergoing experimental potentially immunosuppressive treatment, a patient undergoing Eculizumab treatment, a patient presenting a hereditary immune deficiency).
- For patients in an acute clinical situation:
- Patient previously included in the same sub-population.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Dugoujon Hospital
Caluire-et-Cuire, 69300
Croix Rousse hospital
Lyon, 69004
About this study
Official title: Evaluation of Monocyte Expression of HLA-DR (mHLA-DR) in the Multi-pathological Elderly Subject in Geriatric Service
The acceleration of population aging and the improved management of comorbidities lead to an increase in the number of multi-pathological elderly patients admitted to geriatric services. This is an extremely specific population in terms of immunology due to the presence of immunosenescence (physiological aging of the immune system) and the potential additional effect of multiple chronic pathologies (comorbidities) presented by these patients.
The specific effect of multiple chronic pathologies on the immune status of elderly patients is currently underexplored because most studies on immune system aging only include elderly patients who do not have comorbidities or treatments that could impact the immune system (e.g. SENIEUR protocol). Therefore, their results are not applicable to patients in geriatric services.
Read more
The decrease in monocyte expression of HLA-DR (mHLA-DR) has been studied as a marker of immune alteration in intensive care units in the context of sepsis, but also in chronic pathologies (e.g. cancer, diabetes, renal insufficiency). These chronic pathologies are frequently found in elderly subjects.
The objective of the study would therefore be to investigate the relative contribution of age (immunosenescence) and comorbidities to the alteration of the immune status of geriatric patients through the measurement of mHLA-DR.
To date, no study has explored mHLA-DR in a population of multi-pathological geriatric patients. Our work aims to generate initial data through a pilot study in hospitalized multi-pathological subjects over 75 years old in geriatric services.
- Conditions
- Immune System
- Being tested
- Blood sampling
- Keywords
- Elderly patient, Immune system, mHLA DR, Immunosenescence, Multipathological subject
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Additional blood tube collection during routine blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| Patients in acute medical situation | Patients over 75 with polypathology hospitalised in geriatric wards, in acute situation: for example, patients presenting with an infection, cardiac decompensation, a complicated fall, acute renal failure, any acute or decompensated cardiovascular pathology, any discovery of cancer that has not been stabilised. Receives: Biological: Blood sampling | |
| Patients in stable medical situation | Patients over 75 with polypathology hospitalised in geriatric wards, in a stable situation: these are patients who have not had an episode of decompensation or infection for at least 7 days. Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
mHLA DR expression
Expression of mHLA DR assessed by flow cytometry and expressed as the number of antibodies bound per monocyte.
Measured: up to 72 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start6 Jan 2025
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SystemStudies 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513520
- Sponsor's protocol ID
- 69HCL24_0650
- Other IDs
- ID RCB
- Acronym
- SENIOR HLA DR
- Status last verified
- Jan 2026
- First submitted
- 16 Jul 2024
- Last updated
- 26 Jan 2026
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Monocyte Expression of HLA-DR (mHLA-DR) in the Multi-pathological Elderly Subject in Geriatric Service
- ClinicalTrials.gov ID
- NCT06513520
- Acronym / sponsor ID
- SENIOR HLA DR / 69HCL24_0650
- Conditions
- Immune System
- Keywords
- Elderly patient, Immune system, mHLA DR, Immunosenescence, Multipathological subject
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 22 Jul 2024 (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.
The acceleration of population aging and the improved management of comorbidities lead to an increase in the number of multi-pathological elderly patients admitted to geriatric services. This is an extremely specific population in terms of immunology due to the presence of immunosenescence (physiological aging of the immune system) and the potential additional effect of multiple chronic pathologies (comorbidities) presented by these patients.
The specific effect of multiple chronic pathologies on the immune status of elderly patients is currently underexplored because most studies on immune system aging only include elderly patients who do not have comorbidities or treatments that could impact the immune system (e.g. SENIEUR protocol). Therefore, their results are not applicable to patients in geriatric services.
The decrease in monocyte expression of HLA-DR (mHLA-DR) has been studied as a marker of immune alteration in intensive care units in the context of sepsis, but also in chronic pathologies (e.g. cancer, diabetes, renal insufficiency). These chronic pathologies are frequently found in elderly subjects.
The objective of the study would therefore be to investigate the relative contribution of age (immunosenescence) and comorbidities to the alteration of the immune status of geriatric patients through the measurement of mHLA-DR.
To date, no study has explored mHLA-DR in a population of multi-pathological geriatric patients. Our work aims to generate initial data through a pilot study in hospitalized multi-pathological subjects over 75 years old in geriatric services.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in acute medical situation | – | Biological: Blood samplingPatients over 75 with polypathology hospitalised in geriatric wards, in acute situation: for example, patients presenting with an infection, cardiac decompensation, a complicated fall, acute renal failure, any acute or decompensated cardiovascular pathology, any discovery of cancer that has not been stabilised. |
| Patients in stable medical situation | – | Biological: Blood samplingPatients over 75 with polypathology hospitalised in geriatric wards, in a stable situation: these are patients who have not had an episode of decompensation or infection for at least 7 days. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study will focus on polypathological patients aged over 75 hospitalised in a geriatric ward.
Key inclusion criteria (8 listed)
- Patients aged over 75 hospitalised in one of the geriatric units defined as the research sites;
- Patient affiliated to a social security scheme;
- Patients or relatives who have been informed and have no objections to the research.
- Patients presenting with an acute episode on admission or following a stay in the research sites; The acute episode is defined, for example, by an infection, cardiac decompensation, a complicated fall, acute renal failure, any acute or decompensated cardiovascular pathology, any discovery of cancer that has not been stabilised.
- A patient who has not had an acute episode for at least 7 days.
Key exclusion criteria (7 listed)
- Patients under legal protection: curatorship, guardianship, safeguard of justice ;
- Patients under exclusive comfort care for whom it has been decided not to take a blood sample;
- Patients undergoing long-term antibiotic treatment, i.e. with no defined stopping date;
- An immunocompromised patient or a patient undergoing immunosuppressive treatment (for example: HIV infection, a patient awaiting solid organ transplantation, a patient undergoing haematopoietic stem cell transplantation, a patient undergoing chemotherapy for a solid tumour or haematological malignancy, a patient suffering from an auto-immune disease and being treated with immunotherapy and/or immunosuppressive therapy and/or biotherapy, an asplenic or hyposplenic patient, a patient undergoing experimental potentially immunosuppressive treatment, a patient undergoing Eculizumab treatment, a patient presenting a hereditary immune deficiency).
- Patient previously included in the same sub-population.
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 |
|---|---|---|
| Blood samplingAdditional blood tube collection during routine blood sampling. | Biological | Patients in acute medical situation, Patients in stable medical situation |
Primary outcome
mHLA DR expression
Time frame: up to 72 Hour
Expression of mHLA DR assessed by flow cytometry and expressed as the number of antibodies bound per monocyte.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune System, run by Hospices Civils de Lyon at 2 sites in France.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mHLA DR expression (time frame: up to 72 Hour). 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 26 Jan 2026.