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Hepatitis E Virus Infection in Oncological Patients

NCT06631560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2024-10-08

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

ELISA testing

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

Sponsors & Collaborators

  • Medizinische Hochschule Brandenburg Theodor Fontane

    lead OTHER

Principal Investigators

  • Isabel-Elena Haller · Medical School (MHB) Theodor Fontane

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-10-29
Completion
2024-10-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06631560 on ClinicalTrials.gov