Immunity Against Severe Acute Respiratory Syndrome Coronavirus 2 Disease (COVID-19) in the Oncology Outpatient Setting

Overview

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.

Full Title of Study: “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

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2021

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)

Arms, Groups and Cohorts

  • Outpatient cancer patients
    • Cancer patients who are regularly treated in the Oncology Outpatient Clinic of the University Medical Center Hamburg-Eppendorf (UKE)

Clinical Trial Outcome Measures

Primary Measures

  • Rate of SARS-CoV-2 antibody positive patients
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Up to 1 year
    • Measured in percentage

Secondary Measures

  • Rate of unknown prior COVID19 disease in SARS-CoV-2 antibody positive patients
    • Time Frame: 1 year
    • Measured in percentage
  • Rate of cancer entities in SARS-CoV-2 antibody positive patients
    • Time Frame: 1 year
    • Measured in percentage
  • Rate of therapy modalities in SARS-CoV-2 antibody positive patients
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 1 year
    • Measured in percentage

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitätsklinikum Hamburg-Eppendorf
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marianne Sinn, MD, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
  • Overall Contact(s)
    • Marianne Sinn, MD, +49407410, ma.sinn@uke.de

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