Hepatitis E Virus Infection in Oncological Patients

NCT06631560 | Completed

• 1 other identifier: HepE-Onko-BB
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis E Infection; Hepatitis; Epidemic; Oncologic Disorders

Outcome Measures

Primary Outcomes (1)

• Anti HEV-IgM and IgG prevalences

  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 Outcomes (1)

• Identification of risk factors for HEV infection in oncological patients

  The questionnaire was handed out at the beginning of the study

Study Arms (3)

Oncological disease

EXPERIMENTAL

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

Healthy controls

EXPERIMENTAL

Serum samples were analysed retrospectively using HEV ELISAs

Diagnostic Test: ELISA testing

Control hospitalized due to SARS-CoV-2 infection

EXPERIMENTAL

Serum samples were analysed retrospectively using HEV ELISAs

Diagnostic Test: ELISA testing

Interventions

ELISA testing DIAGNOSTIC_TEST

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

Control hospitalized due to SARS-CoV-2 infection; Healthy controls; Oncological disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• different hemato-oncological entities without age restriction

You may not qualify if:

• patients already receiving antineoplastic therapies
• not given written consent

Sponsors & Collaborators

• Medizinische Hochschule Brandenburg Theodor Fontane: lead

Study Sites (1)

Medical School (MHB) Theodor Fontane

Brandenburg, Brandenburg, 14776, Germany

Location

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Isabel-Elena Haller

  Medical School (MHB) Theodor Fontane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: September 1, 2020
• Primary Completion: October 29, 2021
• Study Completion: October 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)