NCT04772092

Brief Summary

An individual's immune profile changes with age, and can sometimes be involved in the development of certain diseases such as infections or cancers, in a process called immunosenescence. Some data tend to show that there is a link between this immune profile and geriatric fragility (autonomy, difficulties with walking, memory, undernutrition, co-morbidities, depression). The aim of this study is to describe this profile, or immune phenotype, and to see if there is a link with the different aspects of geriatric assessment in patients without cancer or infection. In addition, these data will serve as a basis for comparison with the same analyses performed on breast cancer patients at the Centre Georges François Leclerc.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Status
withdrawn

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

February 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

Same day

First QC Date

February 24, 2021

Last Update Submit

September 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • percentage of immune cells in peripheral blood

    technique used: flow cytometry

    At inclusion

Study Arms (1)

Seniors

70 years of age and over, inpatients or outpatients

Biological: Blood samplesOther: Data collection

Interventions

Blood samplesBIOLOGICAL

during the routine blood test, collection of additional blood samples: * 1 x 5 mL heparinized tube for plasma collection and storage * 1 heparinized 5 mL tube for immunophenotyping * 4 x 10 mL EDTA tubes for white blood cell (WBC) collection and cryopreservation

Seniors

* clinical examination data * test results to measure the degree of geriatric fatigability * Frailty screening questionnaire for neoplasia patients (G8 score)

Seniors

Eligibility Criteria

Age70 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A person at least 70 years of age admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis.

You may qualify if:

  • Male or female aged 70 and over admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis.

You may not qualify if:

  • Person not affiliated to national health insurance system
  • Person subject to a measure of legal safeguard (curatorship, etc)
  • Person with an acute infection
  • Person with suspected cancer or active cancer
  • Long-term immunosuppressive or corticosteroid therapy
  • HIV and/or HBV and/or HCV positive serology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Blood Specimen CollectionData Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health
0

Study Design

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

Study Record Dates

First Submitted

February 24, 2021

First Posted

February 26, 2021

Study Start

November 1, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

September 8, 2022

Record last verified: 2022-09