NCT06513520

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

January 6, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

July 16, 2024

Last Update Submit

January 23, 2026

Conditions

Keywords

Elderly patientImmune systemmHLA DRImmunosenescenceMultipathological subject

Outcome Measures

Primary Outcomes (1)

  • mHLA DR expression

    Expression of mHLA DR assessed by flow cytometry and expressed as the number of antibodies bound per monocyte.

    up to 72 Hour

Study Arms (2)

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.

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.

Biological: Blood sampling

Interventions

Blood samplingBIOLOGICAL

Additional blood tube collection during routine blood sampling.

Patients in acute medical situationPatients in stable medical situation

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will focus on polypathological patients aged over 75 hospitalised in a geriatric ward.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dugoujon Hospital

Caluire-et-Cuire, 69300, France

Location

Croix Rousse hospital

Lyon, 69004, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A sample of blood (4mL EDTA tube and 4ml heparin tube)

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 22, 2024

Study Start

January 6, 2025

Primary Completion

June 23, 2025

Study Completion

June 23, 2025

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations