- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Giza, Egypten
- Cairo University
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27514
- University of North Carolina at Chapel Hill
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Pregnant women with HCV infection
- Pregnant women without HCV infection
Exclusion Criteria:
- None
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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HCV-infected mothers
in situ hybridization
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Uninfected mothers
in situ hybridization
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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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.
Tidsram: 1 year
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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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Samarbetspartners och utredare
Utredare
- Huvudutredare: Ravi Jhaveri, M.D., UNC Department of Pediatrics: Division of Allergy, Immunology, Rheumatology and Infectious Diseases
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 13-0958
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