Hepatitis E Virus Infection in Oncological Patients (HepE-Onko-BB)

October 7, 2024 updated by: Isabel-Elena Haller, Medizinische Hochschule Brandenburg Theodor Fontane

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Brandenburg
      • Brandenburg An Der Havel, Brandenburg, Germany, 14776
        • Medical School (MHB) Theodor Fontane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • different hemato-oncological entities without age restriction

Exclusion Criteria:

  • patients already receiving antineoplastic therapies
  • not given written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oncological disease
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.
Diagnostic test: ELISA testing
Diagnostic testing was performed by testing all serum samples using the HEV ELISA Wantai and Euroimmun kit.
Experimental: Healthy controls
Serum samples were analysed retrospectively using HEV ELISAs
Diagnostic test: ELISA testing
Diagnostic testing was performed by testing all serum samples using the HEV ELISA Wantai and Euroimmun kit.
Experimental: Control hospitalized due to SARS-CoV-2 infection
Serum samples were analysed retrospectively using HEV ELISAs
Diagnostic test: ELISA testing
Diagnostic testing was performed by testing all serum samples using the HEV ELISA Wantai and Euroimmun kit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
The questionnaire was handed out at the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medizinische Hochschule Brandenburg Theodor Fontane

Investigators

  • Principal Investigator: Isabel-Elena Haller, Medical School (MHB) Theodor Fontane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

October 29, 2021

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HepE-Onko-BB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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