Hepatitis E InfectionHepE-Onko-BBNCT06631560
Hepatitis E Virus Infection in Oncological Patients
A study testing ELISA testing in people with Hepatitis E Infection and Hepatitis; Epidemic, run by Medizinische Hochschule Brandenburg Theodor Fontane at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis E Infection, Hepatitis; Epidemic, Oncologic Disorders
- What is being tested?
- ELISA testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2020to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- different hemato-oncological entities without age restriction
Who cannot join
- patients already receiving antineoplastic therapies
- not given written consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical School (MHB) Theodor Fontane
Brandenburg an der Havel, Brandenburg, 14776
About this study
Official title: 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.
- Being tested
- ELISA testing
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA testingDiagnostic test
Diagnostic testing was performed by testing all serum samples using the HEV ELISA Wantai and Euroimmun kit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ELISA testing |
| Healthy controls | Experimental | Serum samples were analysed retrospectively using HEV ELISAs Receives: Diagnostic Test: ELISA testing |
| Control hospitalized due to SARS-CoV-2 infection | Experimental | Serum samples were analysed retrospectively using HEV ELISAs Receives: Diagnostic Test: ELISA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti HEV-IgM and IgG prevalences
Anti-HEV prevalences were determined in each arm with two different assays
Measured: 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
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".
Measured: The questionnaire was handed out at the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Sep 2020
- Primary completion29 Oct 2021
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis E InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel-Elena Haller, Medizinische Hochschule Brandenburg Theodor Fontane
- Investigators
- Isabel-Elena Haller, Principal investigator, Medical School (MHB) Theodor Fontane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631560
- Sponsor's protocol ID
- HepE-Onko-BB
- Acronym
- HepE-Onko-BB
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis E Virus Infection in Oncological Patients - a Prospective Study in Rural Eastern Germany
- ClinicalTrials.gov ID
- NCT06631560
- Acronym / sponsor ID
- HepE-Onko-BB / HepE-Onko-BB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor FontaneUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oncological disease | Experimental | Diagnostic Test: ELISA testingSerum 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. |
| Healthy controls | Experimental | Diagnostic Test: ELISA testingSerum samples were analysed retrospectively using HEV ELISAs |
| Control hospitalized due to SARS-CoV-2 infection | Experimental | Diagnostic Test: ELISA testingSerum samples were analysed retrospectively using HEV ELISAs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- different hemato-oncological entities without age restriction
Key exclusion criteria (2 listed)
- patients already receiving antineoplastic therapies
- not given written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA testingDiagnostic testing was performed by testing all serum samples using the HEV ELISA Wantai and Euroimmun kit. | Diagnostic test | Control hospitalized due to SARS-CoV-2 infection, Healthy controls, Oncological disease |
Primary outcome
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
1 secondary outcome
Identification of risk factors for HEV infection in oncological patients
Time frame: The questionnaire was handed out at the beginning of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel-Elena Haller principal investigator
Medical School (MHB) Theodor Fontane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISA testing in people with Hepatitis E Infection and Hepatitis; Epidemic, run by Medizinische Hochschule Brandenburg Theodor Fontane at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024; AzTrials last refreshed its copy on 3 Nov 2026.