- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02660723
Impact of Aging on Cytokine Production by Innate Immune Cells (Cytokinage)
20. juli 2018 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Frankrig, 06200
- CHU de Nice, CRC, Hôpital de l'Archet 151 route de saint-antoine de ginestière
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: 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.
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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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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CCL2 levels
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Other CCL levels
Tidsramme: at first day
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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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: PASSERON Thierry, PhD, CHU de Nice, Service de Dermatologie
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2016
Primær færdiggørelse (Faktiske)
1. februar 2017
Studieafslutning (Faktiske)
1. juni 2018
Datoer for studieregistrering
Først indsendt
30. november 2015
Først indsendt, der opfyldte QC-kriterier
20. januar 2016
Først opslået (Skøn)
21. januar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 15-PP-07
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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