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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; COVID
• Intervention / Treatment: Other: No Intervention

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Recruiting
    • University Hospital Hamburg Eppendorf
    • Contact: S Guengoer; Email: s.guengoer@uke.de
    • Principal Investigator: Katja Weisel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: University Hopsital Schleswig Holstein Campus Lübeck; Universitätsklinikum Schleswig-Holstein, Campus Kiel
• Investigators: Principal Investigator: Katja Weisel, MD, University Medical Center of Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Anticipated): April 14, 2021
• Study Completion (Anticipated): April 14, 2022

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 14, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PV7313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Aggregated data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No