Clinical trial NCT04779346: Immunity Against Severe Acute Respiratory Syndrome Coronavirus 2 Disease (COVID-19) in the Oncology Outpatient Setting
Official title: Immunity Against Severe Acute Respiratory Syndrome Coronavirus 2 Disease (COVID-19) in the Oncology Outpatient Setting: Prevalence and Serological Immunity in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Covid19
Immunity
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE)

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)

Eligibility 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

Primary outcomes:
measure: Rate of SARS-CoV-2 antibody positive patients
timeFrame: 1 year
measure: Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 antibody positive patients
timeFrame: Up to 1 year
measure: Rate of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients
timeFrame: Up to 1 year
Secondary outcomes:
measure: Rate of unknown prior COVID19 disease in SARS-CoV-2 antibody positive patients
timeFrame: 1 year
measure: Rate of cancer entities in SARS-CoV-2 antibody positive patients
timeFrame: 1 year
measure: Rate of therapy modalities in SARS-CoV-2 antibody positive patients
timeFrame: 1 year
measure: Subgroup analysis of SARS-CoV-2 antibody positivity after 3, 6, 9, 12 months in previously SARS-CoV-2 vaccinated patients
timeFrame: Up to 1 year
measure: Rate of re-infection in SARS-CoV-2 antibody positive patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Marianne Sinn, MD
role: PRINCIPAL_INVESTIGATOR
References: