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

• Conditions: Cancer; COVID

• Registration Number: NCT04408339
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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).

Study Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-05-29
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-14
• Last Update Posted: 2020-06-16
• Primary Completion: 2021-04-14
• Study Completion: 2022-04-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Hamburg Eppendorf; 🇩🇪 Hamburg, Germany