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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06200
        • CHU de Nice, CRC, Hôpital de l'Archet 151 route de saint-antoine de ginestière

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other Names:
  • blood test

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CCL2 levels
Time Frame: at first day
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
at first day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
at first day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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