Clinical trial NCT04408339: COVID-19 in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care Including Biobanking
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
COVID
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: University Hopsital Schleswig Holstein Campus Lübeck
name: University Hospital Schleswig-Holstein
First posted: 2020-05-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population consists of patients, who are treated in the University Cancer Center Hamburg (UCCH) and its contracted partner network, who are either cancer patients reporting a current or past COVID-19 infection, or acute COVID-19 patients who report a prevalent cancer diagnosis.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of hospitalization
timeFrame: 2 years
measure: Duration of hospitalization
timeFrame: 2 years
measure: Rate of admission to intensive care unit
timeFrame: 2 years
measure: Length of stay in intensive care unit
timeFrame: 2 years
measure: Need of mechanical ventilation
timeFrame: 2 years
measure: Duration of mechanical ventilation
timeFrame: 2 years
measure: Disease-specific mortality rate
timeFrame: 2 years
Secondary outcomes:
measure: Rate of patients, whose oncologic treatment had to be modified due to COVID-19
timeFrame: 2 years
measure: Cellular and humoral immune response to COVID-19 infection
timeFrame: 6 month
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg Eppendorf
Study officials:
affiliation: University Medical Center of Hamburg-Eppendorf
name: Katja Weisel, MD
role: PRINCIPAL_INVESTIGATOR
References: