COVIDOUT: Immunity Against Severe Acute Respiratory Syndrome Coronavirus 2 Disease (COVID-19) in the Oncology Outpatient Setting
Study Details
Study Description
Brief Summary
The COVIDOUT study will prospectively investigate the serological immunity of outpatient cancer patients to evaluate the prevalence of previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and dependency of serological immunity on systemic (chemo)therapy after COVID19 disease as well as after vaccination.
Detailed Description
In this prospective observational study all cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE) will be included in the study upon consent.
Data will be collected as follows:
(i) Serological antibody screening at study inclusion and every 3 months (ia) In case of vaccination monthly screening for 3 months (ii) Routine clinical data: demographic and biometric data, medical history, common laboratory parameters (iii) Patient questionnaire: assessment of past COVID-19 infection, past COVID-19 specific symptoms, social environment, vaccination
Recruitment is limited to a one-year period (December 2020 - December 2021)
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Outpatient cancer patients Cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE) |
Outcome Measures
Primary Outcome Measures
- Rate of SARS-CoV-2 antibody positive patients [1 year]
Measured in percentage
- Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 antibody positive patients [Up to 1 year]
Measured in percentage
- Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients [Up to 1 year]
Measured in percentage
Secondary Outcome Measures
- Rate of unknown prior COVID19 disease in SARS-CoV-2 antibody positive patients [1 year]
Measured in percentage
- Rate of cancer entities in SARS-CoV-2 antibody positive patients [1 year]
Measured in percentage
- Rate of therapy modalities in SARS-CoV-2 antibody positive patients [1 year]
Measured in percentage
- Subgroup analysis of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients [Up to 1 year]
Dependency of rate on cancer entity, therapy modality, age, sex and immune status [Measured in percentage]
- Rate of re-infection in SARS-CoV-2 antibody positive patients [1 year]
Measured in percentage
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Known diagnosis of cancer
-
Active disease or (in case of cure) last systemic therapy <12 months
-
Signed informed consent
Exclusion Criteria:
- Refusal of participation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany | 20246 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
Investigators
- Principal Investigator: Marianne Sinn, MD, Universitätsklinikum Hamburg-Eppendorf
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-10275-BO-ff