Geriatrics ImmunosenescencePHENOGERIANCT04772092
Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older
An observational study of Geriatrics Immunosenescence, run by Centre Hospitalier Universitaire Dijon.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Geriatrics Immunosenescence
- What is being tested?
- Blood samples and Data collection
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Older adult
Study population: A person at least 70 years of age admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
- Conditions
- Geriatrics Immunosenescence
- Being tested
- Blood samples, Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Data collectionOther
- clinical examination data
- test results to measure the degree of geriatric fatigability
- Frailty screening questionnaire for neoplasia patients (G8 score)
| Study group | Role | What they receive |
|---|---|---|
| Seniors | 70 years of age and over, inpatients or outpatients Receives: Biological: Blood samples; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of immune cells in peripheral blood
technique used: flow cytometry
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: Departure from the department of the principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatrics ImmunosenescenceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772092
- Sponsor's protocol ID
- BARBEN 2020
- Acronym
- PHENOGERIA
- Status last verified
- Sep 2022
- First submitted
- 24 Feb 2021
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older
- ClinicalTrials.gov ID
- NCT04772092
- Acronym / sponsor ID
- PHENOGERIA / BARBEN 2020
- Conditions
- Geriatrics Immunosenescence
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Departure from the department of the principal investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seniors | – | Biological: Blood samples, Other: Data collection70 years of age and over, inpatients or outpatients |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- A person at least 70 years of age admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesduring 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 | Biological | Seniors |
| Data collection* clinical examination data * test results to measure the degree of geriatric fatigability * Frailty screening questionnaire for neoplasia patients (G8 score) | Other | Seniors |
Primary outcome
percentage of immune cells in peripheral blood
Time frame: At inclusion
technique used: flow cytometry
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
Related trials for Geriatrics Immunosenescence
Active, not recruiting
COVID-19 Serology and Immunosenescence
Covid19, Geriatric Medicine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatrics Immunosenescence, run by Centre Hospitalier Universitaire Dijon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of immune cells in peripheral blood (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.