- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01921400
The Pathogenesis of Hepatitis C Virus Vertical Transmission
To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. In parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ hybridization technique and translate our in vitro findings to these in vivo samples.
Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the placenta serve as a "barrier" that must be crossed during vertical transmission and that cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV regulation should be revealed.
Based on our preliminary data, our working hypothesis is that HCV Core protein is differentially processed in cytotrophoblasts compared to hepatocytes.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Giza, Egypt
- Cairo University
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27514
- University of North Carolina at Chapel Hill
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Pregnant women with HCV infection
- Pregnant women without HCV infection
Exclusion Criteria:
- None
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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HCV-infected mothers
in situ hybridization
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Uninfected mothers
in situ hybridization
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively.
Tidsramme: 1 year
|
We will begin by examining paraffin-embedded sections from HCV-infected mothers who had the placentas sent to pathology for analysis.We will perform a combination of immunohistochemistry (IHC) and immunofluorescence (IF) to analyze the level of SPP expression in the trophoblast cell layer, as well as if HCV Core protein expression was detectable in this layer or in any cell type within the placental section. We would also plan to identify other patient-derived tissues that were not paraffin embedded, both from uninfected patients and infected patients to validate different parts of our preliminary data. We would plan to use dissected fetal membranes, which contain both chorion and amnion, to investigate the level of SPP expression in these tissues. |
1 year
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ravi Jhaveri, M.D., UNC Department of Pediatrics: Division of Allergy, Immunology, Rheumatology and Infectious Diseases
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 13-0958
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