Cancer Clinical Trial
— COVIDHELPOfficial title:
COVID-19 Disease in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care in the Hamburg Metropolitan Area Including Prospective Biobanking
NCT number | NCT04408339 |
Other study ID # | PV7313 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 15, 2020 |
Est. completion date | April 14, 2022 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Hamburg Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | Universitätsklinikum Schleswig-Holstein, Campus Kiel, University of Schleswig-Holstein, Campus Lübeck |
Germany,
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 |
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