Hepatitis E Virus Infection in Oncological Patients

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.

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Key information

Conditions

Hepatitis E Infection Digestive System Diseases Hepatitis Hepatitis; Epidemic Liver Diseases Oncologic Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical School (MHB) Theodor Fontane

Brandenburg an der Havel, Brandenburg, 14776, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

different hemato-oncological entities without age restriction

Exclusion criteria

patients already receiving antineoplastic therapies
not given written consent

Treatment and study plan

ELISA testing

Diagnostic Test

Diagnostic testing was performed by testing all serum samples using the HEV ELISA Wantai and Euroimmun kit.

Primary outcomes

Anti HEV-IgM and IgG prevalences

Time frame: 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 outcomes

Identification of risk factors for HEV infection in oncological patients

Time frame: 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".

Sponsors and collaborators

Lead sponsor

Medizinische Hochschule Brandenburg Theodor Fontane

Other

Registry information

Official study title

Hepatitis E Virus Infection in Oncological Patients - a Prospective Study in Rural Eastern Germany

Acronym: HepE-Onko-BB

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2024
First posted: Oct 8, 2024
Registry last updated: Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed