COVID-19 in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care Including Biobanking

Study Overview
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Brief Summary
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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
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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).

Official Title
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COVID-19 Disease in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care in the Hamburg Metropolitan Area Including Prospective Biobanking

Conditions
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Cancer, COVID

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Key inclusion criteria: Known diagnosis of cancer Known diagnosis of CoVID-19 infection Age ≥ 18 years Signed informed consent Key exclusion criteria: • refusal of participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|No Intervention|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hospitalization | Measured in percentage | 2 years | 
| Duration of hospitalization | Measured in days from date of admission to definitive discharge | 2 years | 
| Rate of admission to intensive care unit | Measured in percentage | 2 years | 
| Length of stay in intensive care unit | Measured in days from date of admission to intensive care unit to the date of discharge | 2 years | 
| Need of mechanical ventilation | Measured in percentage | 2 years | 
| Duration of mechanical ventilation | Measured in days from the date of intubation to the stop date of mechanical ventilation | 2 years | 
| Disease-specific mortality rate | COVID-19 associated mortality rate | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients, whose oncologic treatment had to be modified due to COVID-19 | Measured in percentage. Modification is defined as cancellation, postponement or dose-adjustment of treatment. | 2 years | 
| Cellular and humoral immune response to COVID-19 infection | Analysis of blood samples at time of diagnosis and after 6 month | 6 month |