Impact of Age and Geriatric Co-morbidities on Lymphocyte... | NCT04772092

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

NCT04772092

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Withdrawn

Last Update Posted

Sep 8, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Geriatrics Immunosenescence

Interventions

Blood samples
Data collection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Departure from the department of the principal investigator

Expanded Access Info

Start Date

Nov 2021Estimated

Primary Completion Date

Nov 2021Estimated

Completion Date

Nov 2021Estimated

First Submitted Date

Feb 24, 2021

First Submission Date that Met QC Criteria

Feb 24, 2021

First Posted Date

Feb 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2022

Last Update Posted Date

Sep 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Seniors		70 years of age and over, inpatients or outpatients	Biological: Blood samples Other: Data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood samples	Biological	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D003625	Data Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

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