Hepatitis E Virus Infection in Oncological Patients

Not Applicable

Completed

• Conditions: Hepatitis E Infection; Hepatitis; Epidemic; Oncologic Disorders
• Interventions: Diagnostic Test: ELISA testing

• Registration Number: NCT06631560
• Lead Sponsor: Medizinische Hochschule Brandenburg Theodor Fontane

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-10-29
• Status Verified: 2024-10
• Study Completion: 2024-10-01
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

Inclusion Criteria

• different hemato-oncological entities without age restriction

Exclusion Criteria

• patients already receiving antineoplastic therapies
• not given written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oncological disease	ELISA testing	Serum was taken from each patient before treatment initiation and during treatment follow-up. In addition, oncological participants completed a questionnaire consisting of eight questions focusing on quantitative aspects, to identify risk factors for HEV infection.
Healthy controls	ELISA testing	Serum samples were analysed retrospectively using HEV ELISAs
Control hospitalized due to SARS-CoV-2 infection	ELISA testing	Serum samples were analysed retrospectively using HEV ELISAs

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (1)

Medical School (MHB) Theodor Fontane; 🇩🇪 Brandenburg An Der Havel, Brandenburg, Germany