COVID-19 Disease in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care in the Hamburg Metropolitan Area Including Prospective Biobanking
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Duration of hospitalization
- Last Updated
- 5 years ago
Overview
Brief Summary
The COVIDHELP study will prospectively evaluate the yet unknown clinical course of the COVID-19 infection in cancer patients and document the impact of potential infrastructural limitations on cancer care of COVID-19 positive patients. All patients consenting will provide peripheral blood samples for prospective biobanking with the aim of investigating immune response and immunity against COVID-19.
Detailed Description
Based on patients, who are treated in the University Cancer Center Hamburg (UCCH) and its contracted partner network, which comprises all cancer treating departments at the University Medical Center of Hamburg-Eppendorf (UKE), as well as 19 office-based oncologists and 20 surrounding hospitals, recruitment for the study will be done as follows: (i) as a cancer patient during regular aftercare appointments who reports a current or past COVID-19 infection. (ii) as an acute COVID-19 patient who reports a prevalent cancer diagnosis Data will be collected as available from routine clinical care and includes demographic and biometric data, medical history, baseline data at inclusion as well as inpatient and intensive care unit admissions. Upon consent, patients will provide peripheral blood samples at time of inclusion and after 6 month. Recruitment is limited to a one-year period (April 2020 - April 2021).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Duration of hospitalization
Time Frame: 2 years
Measured in days from date of admission to definitive discharge
Rate of hospitalization
Time Frame: 2 years
Measured in percentage
Rate of admission to intensive care unit
Time Frame: 2 years
Measured in percentage
Length of stay in intensive care unit
Time Frame: 2 years
Measured in days from date of admission to intensive care unit to the date of discharge
Need of mechanical ventilation
Time Frame: 2 years
Measured in percentage
Duration of mechanical ventilation
Time Frame: 2 years
Measured in days from the date of intubation to the stop date of mechanical ventilation
Disease-specific mortality rate
Time Frame: 2 years
COVID-19 associated mortality rate
Secondary Outcomes
- Rate of patients, whose oncologic treatment had to be modified due to COVID-19(2 years)
- Cellular and humoral immune response to COVID-19 infection(6 month)