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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient cancer patients | Cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE) |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of SARS-CoV-2 antibody positive patients | Measured in percentage | 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 | 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 | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of unknown prior COVID19 disease in SARS-CoV-2 antibody positive patients | Measured in percentage | 1 year |
| Rate of cancer entities in SARS-CoV-2 antibody positive patients | Measured in percentage |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marianne Sinn, MD | Contact | +49407410 | 0 | ma.sinn@uke.de |
| Martin Schönlein, MD | Contact | +49407410 | 0 | m.schoenlein@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Marianne Sinn, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
Aggregated data will be shared
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 1 year |
| Rate of therapy modalities in SARS-CoV-2 antibody positive patients | Measured in percentage | 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] | Up to 1 year |
| Rate of re-infection in SARS-CoV-2 antibody positive patients | Measured in percentage | 1 year |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |