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.
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 Type
OBSERVATIONAL
Enrollment
500
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGRate of SARS-CoV-2 antibody positive patients
Measured in percentage
Time frame: 1 year
Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 antibody positive patients
Measured in percentage
Time frame: Up to 1 year
Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients
Measured in percentage
Time frame: Up to 1 year
Rate of unknown prior COVID19 disease in SARS-CoV-2 antibody positive patients
Measured in percentage
Time frame: 1 year
Rate of cancer entities in SARS-CoV-2 antibody positive patients
Measured in percentage
Time frame: 1 year
Rate of therapy modalities in SARS-CoV-2 antibody positive patients
Measured in percentage
Time frame: 1 year
Subgroup analysis of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients
Dependency of rate on cancer entity, therapy modality, age, sex and immune status \[Measured in percentage\]
Time frame: Up to 1 year
Rate of re-infection in SARS-CoV-2 antibody positive patients
Measured in percentage
Time frame: 1 year
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