Hepatitis E Virus Infection in Oncological Patients

NCT ID: NCT06631560

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis E Infection Hepatitis; Epidemic Oncologic Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

ELISA testing

Intervention Type DIAGNOSTIC_TEST

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

Healthy controls

Serum samples were analysed retrospectively using HEV ELISAs

Group Type EXPERIMENTAL

ELISA testing

Intervention Type 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

Serum samples were analysed retrospectively using HEV ELISAs

Group Type EXPERIMENTAL

ELISA testing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ELISA testing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* different hemato-oncological entities without age restriction

Exclusion Criteria

* patients already receiving antineoplastic therapies
* not given written consent
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medizinische Hochschule Brandenburg Theodor Fontane

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Isabel-Elena Haller

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Isabel-Elena Haller

Role: PRINCIPAL_INVESTIGATOR

Medical School (MHB) Theodor Fontane

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical School (MHB) Theodor Fontane

Brandenburg, Brandenburg, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HepE-Onko-BB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.