- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02660723
Impact of Aging on Cytokine Production by Innate Immune Cells (Cytokinage)
July 20, 2018 updated by: Centre Hospitalier Universitaire de Nice
To Investigate the Impact of Aging on Cytokine and Chemokine Production by Peripheral Blood Immune Cells
The main goal of this study is to investigate the impact of aging on the responsiveness of peripheral blood immune cells.
To this aim, the investigators will take advantage of a recently described syringe-based assay system that can reproducibly assess induced, innate or adaptive immune responses.
Briefly, a total of 50 healthy volunteers will participate to this study: 25 will be older than 18 and younger than 30, and 25 will be older than 55.
A total of 14 ml of blood will be drawn including 5 X 1 ml in TruCulture™ tubes containing poly(I:C), R-848, LPS, CpG, or no stimulus, respectively.
After 22 hours of incubation at 37°C, cellular supernatants will assessed for levels of 10 different chemokines using a MesoScaleDiscovery multiplexing platform.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alpes-Maritimes
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Nice, Alpes-Maritimes, France, 06200
- CHU de Nice, CRC, Hôpital de l'Archet 151 route de saint-antoine de ginestière
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- volunteers will be invited to settle an appointment with the Nice University Hospital (CHU de Nice) Research Clinical Center (CRC).
- being between 18 and 30 year-old (group Y) or being older than 55 year-old (group O),
- ability to understand and speak French,
- being registered at the Social Security,
- acceptance to be serologically tested for HIV and HVC,
- considered healthy based on both past medical records and the clinical examination performed at the inclusion visit,
- exhibiting a body mass index (body mass divided by the square of their height) comprised between 18.5 and 30.0 kg/m2.
Exclusion Criteria:
- having participated to a drug clinical trial since less than 3 months,
- having traveled to a tropical or a sub-tropical country over the past 3 months,
- being pregnant or a lactating mother (for women),
- having performed intensive physical exercise over the past 12 hours,
- following a specific diet for medical reasons,
- over-drinking, i.e. more that 50 g of pure alcohol every day,
- having taken an immuno-suppressive or immuno-modulatory drug over the past two weeks, or for at least 14 consecutive days over the past 6 months,
- having been vaccinated over the past 3 months,
- declaring not being on an empty stomach for less than 12 hours,
- having received a blood transfusion or intravenous immunoglobulins over the past 3 months,
- declaring being HIV- or HVC- positive,
- having suffered from an infection since less than 3 weeks,
- exhibiting a positive urine pregnancy test at the inclusion visit,
- suffering from a severe/chronic/relapsing pathology, i.e. inflammatory bowel disease, psoriasis, atopic dermatitis, rheumatoid arthritis, multiple sclerosis, type I or type II diabetes, Parkinson's disease, and (p) having been diagnosed with a cancer and not being in a remitting period for less than 5 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Healthy Volunteers
A catheter will be introduced in the arm vein and 14 ml of blood will be drawn in one 4 ml dry tube, one 5 ml heparinized tube for cell count and 5 1 ml TruCulture tubes.
|
A catheter will be introduced in the arm vein and 14 ml of blood will be drawn in one 4 ml dry tube, one 5 ml heparinized tube for cell count and 5 1 ml TruCulture tubes.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CCL2 levels
Time Frame: at first day
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Compare CCL2 levels in the supernatants of poly(I :C)-stimulated whole blood cells between volunteers aged from 18 to 30 years and volunteers older than 55
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at first day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other CCL levels
Time Frame: at first day
|
Compare CXCL8 (IL-8) levels in the supernatants of poly(I :C)-stimulated whole blood cells between volunteers aged from 18 to 30 years and volunteers older than 55
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at first day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: passeron thierry, PhD, CHU de Nice, Service de Dermatologie
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
November 30, 2015
First Submitted That Met QC Criteria
January 20, 2016
First Posted (Estimate)
January 21, 2016
Study Record Updates
Last Update Posted (Actual)
July 23, 2018
Last Update Submitted That Met QC Criteria
July 20, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15-PP-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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