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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04772092
Recruitment Status : Not yet recruiting
First Posted : February 26, 2021
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Study Description
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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.

Condition or disease Intervention/treatment
Geriatrics Immunosenescence Biological: Blood samples Other: Data collection

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021
Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. percentage of immune cells in peripheral blood [ Time Frame: At inclusion ]
    technique used: flow cytometry


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes 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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772092


Contacts
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Contact: Jérémy BARBEN 03 80 29 30 17 jeremy.barben@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21000
Contact: Jérémy BARBEN    03 80 29 30 17    jeremy.barben@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
More Information
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT04772092    
Other Study ID Numbers: BARBEN 2020
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No