Hepatitis E Infection, Hepatitis; Epidemic, Oncologic Disorders
Conditions
Brief summary
The goal of this clinical trial is to investigate the prevalence of hepatitis E infection in oncological patients in a rural region of Germany. Consequently, we conducted prospective testing of blood samples from patients with haematological malignancies for evidence of HEV infection using two distinct anti-HEV IgG and IgM enzyme-linked immunosorbent assays (ELISAs). Serum was taken from each patient before treatment initiation and during treatment follow-up. Primary endpoint was determination of HEV seroprevalence. A healthy cohort was established alongside a cohort of patients who had been hospitalised due to a diagnosis of SARS-CoV-2 infection. In addition, oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for HEV infection.
Interventions
DIAGNOSTIC_TESTELISA testing
Diagnostic testing was performed by testing all serum samples using the HEV ELISA Wantai and Euroimmun kit.
Sponsors
Medizinische Hochschule Brandenburg Theodor Fontane
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* different hemato-oncological entities without age restriction
Exclusion criteria
* patients already receiving antineoplastic therapies * not given written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti HEV-IgM and IgG prevalences | In the oncological cohort, multiple samples were prospectively collected over a one-year period, commencing on 1 September 2020 and concluding at the end of October 2021. In the remaining two control samples, analysis was conducted retrospectively. | Anti-HEV prevalences were determined in each arm with two different assays |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of risk factors for HEV infection in oncological patients | The questionnaire was handed out at the beginning of the study | Oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for HEV infection. Part of the questions were posed in a binary format, requiring a yes or no response. Additionally, we inquired as to the frequency with which risk factors such as pork are consumed. A multiple-choice format was employed, with the majority of questions comprising single-select multiple-choice options. To illustrate, the question for example enquired as to the frequency with which the patient consumed raw or undercooked pork products. The options ranged from never to more than once a month. |
Countries
Germany
Outcome results
None listed