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
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2020
CompletedFirst Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2022
CompletedJune 16, 2020
June 1, 2020
12 months
May 19, 2020
June 14, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
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 Outcomes (2)
Rate of patients, whose oncologic treatment had to be modified due to COVID-19
2 years
Cellular and humoral immune response to COVID-19 infection
6 month
Interventions
No Intervention
Eligibility Criteria
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.
You may qualify if:
- Known diagnosis of cancer
- Known diagnosis of CoVID-19 infection
- Age ≥ 18 years
- Signed informed consent
You may not qualify if:
- refusal of participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Hamburg Eppendorf
Hamburg, Germany
Biospecimen
Peripheral Blood
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Katja Weisel, MD
University Medical Center of Hamburg-Eppendorf
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2020
First Posted
May 29, 2020
Study Start
April 15, 2020
Primary Completion
April 14, 2021
Study Completion
April 14, 2022
Last Updated
June 16, 2020
Record last verified: 2020-06