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Immunological Characterization of Blood of Normal Individuals

1. november 2021 opdateret af: Ohio State University
This study seeks to obtain normal samples of blood, saliva and urine to serve as controls for other approved protocols and for analysis. These include determination of the functional capabilities of cells, proteins, nucleic acids and microvesicles obtained from peripheral blood including plasma, serum and cellular fraction from normal individuals. Saliva and urine will have similar testing which may also be compared to the blood testing results. The ongoing objective varies from investigation to investigation but in general the investigational goals are to better understand the immune function of normal volunteers and compare it to immune function in disease states.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Blood will be obtained via peripheral venipuncture. The blood will be divided into components (e.g. plasma, serum, microvesicles, and cells) then analyzed. Flow cytometry will be used to determine cell and microvesicle subsets. RNA will be extracted from the various components of blood and will be subjected to gene and microRNA profiling to determine gene expression. DNA will be isolated from the cells to be used in studies investigating epigenetic regulation of genes identified in the screens. Protein will also be isolated from the multiple components to examine the impact of genetic regulation by epigenetic mechanisms or microRNA on protein expression. Peripheral blood mononuclear cells will be placed in tissue culture for study.

Saliva and urine will be obtained the same day as blood for testing.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants may also be recruited by word of mouth or via public advertising. This study is open to all eligibile healthy adult volunteers regardless of gender, age and ethnicity.

Beskrivelse

Inclusion Criteria:

  • Healthy with no chronic or acute illnesses, or taking medication which in the opinion of the PI would impact the analyses being conducted.
  • At least 18 years or older.
  • Are capable of reading, understanding and providing written informed consent.

Exclusion Criteria:

  • Non-English speaking.
  • Individuals under 18 years old.
  • Woman who believe they are or may be pregnant. (Based on self reporting. Pregnancy testing will not be conducted for the purposes of this study)
  • Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted.
  • Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted.
  • Individual has donated blood more than twice in the last week or the amount to be drawn will exceed the maximum allowance in the last 8 weeks.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Healthy Volunteer
Healthy Volunteer without lung disease
Andet: Ingen indgriben
Der er ingen intervention til denne undersøgelse

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood content differences between the lung disease and healthy control populations
Tidsramme: Day 1
Test for differences in the blood of individuals with lung disease and normal healthy controls.
Day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Genetic expression of relevant genes between the lung disease and healthy control populations
Tidsramme: Day 1
Test for genetic differences in the blood of individuals with lung disease and normal healthy controls.
Day 1
Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.
Tidsramme: Day 1
Analyze saliva and urine along with the blood sample in order to compare the information in the blood with the saliva and urine.
Day 1
Identify diagnostic and prognostic indicators for lung disease
Tidsramme: December 2020
Develop and test possible diagnostic and prognostic indicators for various lung diseases.
December 2020
Develop possible treatment for lung disease
Tidsramme: December 2020
Develop and test possible reprogramming of blood cells to promote vessel formation as a way to prevent tumor metastases and modify the progression of specific lung diseases.
December 2020

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ohio State University

Efterforskere

  • Ledende efterforsker: Clay Marsh, M.D., Ohio State University

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. marts 2011

Primær færdiggørelse (Faktiske)

5. januar 2015

Studieafslutning (Faktiske)

5. januar 2015

Datoer for studieregistrering

Først indsendt

27. april 2011

Først indsendt, der opfyldte QC-kriterier

30. juni 2011

Først opslået (Skøn)

1. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2011H0007

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 .

Kliniske forsøg med Ingen indgriben

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner