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

Medizinische Hochschule Brandenburg Theodor Fontane

Status: Completed

Conditions: Hepatitis E Infection; Hepatitis; Epidemic; Oncologic Disorders

Treatments: Diagnostic Test: ELISA testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06631560

HepE-Onko-BB

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• different hemato-oncological entities without age restriction

Exclusion criteria

• patients already receiving antineoplastic therapies
• not given written consent

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 3 patient groups

Oncological disease

Experimental group

Description:

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.

Treatment:

Diagnostic Test: ELISA testing

Healthy controls

Experimental group

Description:

Serum samples were analysed retrospectively using HEV ELISAs

Treatment:

Diagnostic Test: ELISA testing

Control hospitalized due to SARS-CoV-2 infection

Experimental group

Description:

Serum samples were analysed retrospectively using HEV ELISAs

Treatment:

Diagnostic Test: ELISA testing