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

Cancer Clinical Trial

— COVIDHELP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04408339
• Other study ID #: PV7313
• Status: Recruiting
• Start date: April 15, 2020
• Est. completion date: April 14, 2022

Study information

• Verified date: June 2020
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Katja Weisel, MD
• Phone: +49407410
• Email: k.weisel[@]uke.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• COVID

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
Germany	University Hospital Hamburg Eppendorf	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Universitätsklinikum Schleswig-Holstein, Campus Kiel, University of Schleswig-Holstein, Campus Lübeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hospitalization	Measured in percentage	2 years
Primary	Duration of hospitalization	Measured in days from date of admission to definitive discharge	2 years
Primary	Rate of admission to intensive care unit	Measured in percentage	2 years
Primary	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
Primary	Need of mechanical ventilation	Measured in percentage	2 years
Primary	Duration of mechanical ventilation	Measured in days from the date of intubation to the stop date of mechanical ventilation	2 years
Primary	Disease-specific mortality rate	COVID-19 associated mortality rate	2 years
Secondary	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
Secondary	Cellular and humoral immune response to COVID-19 infection	Analysis of blood samples at time of diagnosis and after 6 month	6 month