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| ID | Type | Description | Link |
|---|---|---|---|
| 05/OR-FNOs/2024 | Other Grant/Funding Number | University Hospital Ostrava |
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In this study, the researchers want to focus on the prevalence of anti-HEV antibodies by a new generation test, direct detection of HEV RNA, and its genotypic analysis in a group of human tissue and cell donors.
At the Department of Laboratory Medicine of the Faculty of Medicine of the Faculty of Medicine of the National University of Health Sciences, human tissue and cells from donors will be examined for the assessment of health eligibility and donor selection according to Decree No. 422/2008 Coll. According to the current legislation, the determination of IgG and IgM antibodies against HEV or the HEV RNA method is not part of the standard examination of human tissue and cell donors for the assessment of their health eligibility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Organ Donors | Experimental | Samples obtained from organ donors will be included in this study arm. |
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| Cell Donors | Experimental | Samples obtained from cell donors will be included in this study arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elecsys Anti-HEV IgG, IgM | Diagnostic Test | Diagnostic test used to determine antibodies in blood and serum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Hepatitis E in the study groups | The prevalence of Hepatitis E will be observed in both study groups, measured as the number of positive samples from the total number of samples. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Hepatitis E (HEV) RNA in the study groups | The presence of HEV RNA will be observed in both study groups, measured as the number of positive samples from the total number of samples. | 2 years |
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Inclusion Criteria:
- patients indicated for organ or cell donation
Exclusion Criteria:
- none
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | 0042059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Hana Slepčanová, Mgr. | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 708 52 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28194857 | Background | Tedder RS, Ijaz S, Kitchen A, Ushiro-Lumb I, Tettmar KI, Hewitt P, Andrews N. Hepatitis E risks: pigs or blood-that is the question. Transfusion. 2017 Feb;57(2):267-272. doi: 10.1111/trf.13976. | |
| 31284447 | Background | Horvatits T, Schulze Zur Wiesch J, Lutgehetmann M, Lohse AW, Pischke S. The Clinical Perspective on Hepatitis E. Viruses. 2019 Jul 5;11(7):617. doi: 10.3390/v11070617. |
| Label | URL |
|---|---|
| World Health Organization. Hepatitis E: Fact sheet | View source |
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There is no plan to make individual participant data available to other researchers.
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| ID | Term |
|---|---|
| D016751 | Hepatitis E |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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The study subjects and their samples will be divided into two study groups.
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No masking will be used in the study.
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| 29154369 | Background | Kamar N, Izopet J, Pavio N, Aggarwal R, Labrique A, Wedemeyer H, Dalton HR. Hepatitis E virus infection. Nat Rev Dis Primers. 2017 Nov 16;3:17086. doi: 10.1038/nrdp.2017.86. |
| 26174470 | Background | Blasco-Perrin H, Madden RG, Stanley A, Crossan C, Hunter JG, Vine L, Lane K, Devooght-Johnson N, Mclaughlin C, Petrik J, Stableforth B, Hussaini H, Phillips M, Mansuy JM, Forrest E, Izopet J, Blatchford O, Scobie L, Peron JM, Dalton HR. Hepatitis E virus in patients with decompensated chronic liver disease: a prospective UK/French study. Aliment Pharmacol Ther. 2015 Sep;42(5):574-81. doi: 10.1111/apt.13309. Epub 2015 Jul 14. |
| 25755504 | Background | Kumar A, Saraswat VA. Hepatitis E and Acute-on-Chronic Liver Failure. J Clin Exp Hepatol. 2013 Sep;3(3):225-30. doi: 10.1016/j.jceh.2013.08.013. Epub 2013 Sep 16. |
| 28374592 | Background | Nemecek V, Butovicova P, Maly M, Dite P, Vertatova M, Vodickova I, Kriz B. [The prevalence of antibodies against Hepatitis E Virus in the Czech Republic: serological survey]. Epidemiol Mikrobiol Imunol. 2017 Winter;66(1):3-7. Czech. |
| 41545967 | Derived | Slepcanova H, Glac T, Konde A, Harazimova A, Kusnierova P. Molecular and serodetection of hepatitis E virus among organ donors in the Czech Republic. BMC Infect Dis. 2026 Jan 16;26(1):319. doi: 10.1186/s12879-026-12567-5. |
| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |