Sickle Cell Disease Biofluid Chip Technology (SCD BioChip)
5. januar 2024 oppdatert av: AOwusu-Ansah, University Hospitals Cleveland Medical Center
Sigdcellesykdom (SCD) Biochip': Mot en enkel og pålitelig måte å overvåke sigdcellesykdom
'Sigdformet' anemi ble først klinisk beskrevet i USA i 1910, og det muterte arvelige sigdhemoglobinmolekylet ble identifisert i 1949. Patofysiologien til SCD er en konsekvens av unormal polymerisering av sigdhemoglobin (HbS) og dets effekter på røde blodlegemers membranegenskaper, form og tetthet, og påfølgende kritiske endringer i funksjon av inflammatoriske celler og endotelceller. Målet vårt er å forstå virkningen av CMA-avvik ved SCD, ved å avhøre en rekke anerkjente interaksjoner i en rekke kliniske fenotyper.
Til dags dato har korrelative studier i SCD, av oss og andre, varierer mellom kliniske rapporter, basert på tester, intervensjoner og kartgjennomgang av individer eller grupper av individer og, i den andre ytterligheten, identifisering av funksjonelle genpolymorfismer basert på populasjonsstudier . Etterforskerne ønsker å utvide disse studiene gjennom en systematisk undersøkelse av cellulære membranegenskaper og aktiveringsstatus. Av hematologiske lidelser kan SCD være uvanlig mottakelig for en slik undersøkelse.
Studieoversikt
Detaljert beskrivelse
Ny biofluidisk brikketeknologi kan undersøke overflatekarakteristikker som typisk måles med konvensjonelle teknikker, for eksempel fluorescerende aktivert cellesortering (FACS), immunhistokjemi eller mikroskopiske avbildningsmetoder.
I FACS blir celler av interesse isolert, omfattende prosessert, inkubert med et fluorescensmerket antistoff og sortert ved optisk gjenkjenning.
I den foreslåtte SCD-biofluidbrikken (SCD-biochip), dekker det spørrende antistoffet mikrokanaloverflaten og fanger opp cellepopulasjonen(e) av interesse, uten prosessering, inkubasjon eller in vitro-manipulasjon.
SCD-biobrikken kan også kvantifisere cellulær adherens til eksperimentelle biologiske overflater som består av subcellulære komponenter.
SCD-biobrikken er teknisk enkel og eksperimentelt fleksibel, der populasjonen av interesse beholdes på brikken og kvantifiseres in situ.
Mikrobrikkesystemet tillater uthenting av levedyktige isolerte celler for potensiell nedstrøms prosessering, analyse og in vitro-kultur.
Studietype
Observasjonsmessig
Registrering (Antatt)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Umut Gurkan, PhD
- Telefonnummer: (216) 368-6447
- E-post: umut@case.edu
Studiesteder
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Rekruttering
- University Hospitals Case Medical Center
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Ta kontakt med:
- Umut A Gurkan, Ph.D.
- Telefonnummer: 216-368-6447
- E-post: umut@case.edu
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Hovedetterforsker:
- Amma Owusu-Ansah, MD
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Ta kontakt med:
- Amma Owusu-Ansah, MD
- Telefonnummer: 216-844-3345
- E-post: Amma.Owusu-Ansah@UHhospitals.org
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
12 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Barn (≥12 år) og voksne med SCD, inkludert HbSS eller sammensatt heterozygus HbSC- eller HbSβ-thalassemi vil bli tilbudt deltakelse.
Kontrollprøver (HbAA) kan fås fra friske frivillige.
Beskrivelse
Inklusjonskriterier
- Mann eller kvinne ≥12 år på tidspunktet for samtykke (påmelding).
- Dokumentasjon Sigdcellesykdom, inkludert HbSS eller sammensatt heterozygus HbSC- eller HbSβ-thalassemidiagnose som dokumentert av ett eller flere kliniske trekk.
- Skriftlig informert samtykke (og samtykke når det er aktuelt) innhentet fra fagets eller subjektets juridiske representant og evnen for subjektet til å overholde kravene til studien.
Eksklusjonskriterier
- Tilstedeværelse av en tilstand eller abnormitet som etter etterforskerens mening ville kompromittere pasientens sikkerhet eller kvaliteten på dataene.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Mindre SCD-gruppe, 12-17 år
Ingen inngrep.
Kun bruk av kassert blod/vev
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Ingen inngrep.
Bruk av kassert blod/vev
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Voksen SCD. Alder 18+
Ingen inngrep.
Kun bruk av kassert blod/vev
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Ingen inngrep.
Bruk av kassert blod/vev
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Utvikle en SCD-biochip for å undersøke sentrale cellulære egenskaper og interaksjoner, inkludert RBC og WBC cellulære, adhesive og inflammatoriske egenskaper, og sirkulerende endoteliale og hematopoietiske forløpercellers egenskaper.
Tidsramme: 2 år
|
Adhesjon av røde og hvite celler til biomolekyler (f.
laminin, fibronektin og selektiner) vil bli målt på en mikrofluidisk enhet, SCD Biochip.
Adhesjon vil bli målt under normale oksygen- og lavoksygenforhold.
Adhesjoner vil bli vurdert i forhold til kliniske funn, som hematologiske parametere, og bevis for vaso-okklusjon, smerte, inflammasjon og vaskulopati hos pasienter med sigdcellesykdom.endotelial
og hematopoietiske forløperceller basert på membranegenskaper og adhesjon.
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2 år
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Korrelere SCD Biochip-funksjon i heterogene SCD-populasjoner, inkludert HbSS og HbSC i en rekke aldre, og i de med akutte og kroniske komplikasjoner og sammenlignet med normale kontroller.
Tidsramme: 2 år
|
Etterforskerne vil undersøke og validere kliniske korrelasjoner med disse cellulære/membranegenskapene i større populasjoner av SCD, på tvers av en rekke fenotyper, ved å bruke vår enkle hurtige fleksible SCD Biochip-plattform.
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2 år
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Amma Owusu-Ansah, MD, University Hospitals Cleveland Medical Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2014
Primær fullføring (Antatt)
1. mai 2024
Studiet fullført (Antatt)
1. mai 2024
Datoer for studieregistrering
Først innsendt
27. mai 2015
Først innsendt som oppfylte QC-kriteriene
5. juli 2016
Først lagt ut (Antatt)
6. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. januar 2024
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. januar 2024
Sist bekreftet
1. januar 2024
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 05-14-07C
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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