Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older (PHENOGERIA)

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.

Study Overview

• Status: Withdrawn
• Conditions: Geriatrics Immunosenescence
• Intervention / Treatment: Biological: Blood samples; Other: Data collection

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 68 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Person who has not opposed to inclusion in the study
• Male or female aged 70 and over admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Seniors; 70 years of age and over, inpatients or outpatients

Biological: Blood samples; 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; Other: Data collection; clinical examination data; test results to measure the degree of geriatric fatigability; Frailty screening questionnaire for neoplasia patients (G8 score)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of immune cells in peripheral blood	technique used: flow cytometry	At inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BARBEN 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No