CancerCOVIDHELPNCT04408339
COVID-19 in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care Including Biobanking
An observational study of Cancer and COVID, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2020to 14 Apr 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Known diagnosis of cancer
- Known diagnosis of CoVID-19 infection
- Age ≥ 18 years
- Signed informed consent
Who cannot join
- refusal of participation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Hamburg Eppendorf
Hamburg
S Guengoer, s.guengoer@uke.de
Katja Weisel, MD
About this study
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
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.
Read the 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).
- Being tested
- No Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hospitalization
Measured in percentage
Measured: 2 years
Duration of hospitalization
Measured in days from date of admission to definitive discharge
Measured: 2 years
Rate of admission to intensive care unit
Measured in percentage
Measured: 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
Measured: 2 years
Need of mechanical ventilation
Measured in percentage
Measured: 2 years
Duration of mechanical ventilation
Measured in days from the date of intubation to the stop date of mechanical ventilation
Measured: 2 years
Disease-specific mortality rate
COVID-19 associated mortality rate
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 2 years
Cellular and humoral immune response to COVID-19 infection
Analysis of blood samples at time of diagnosis and after 6 month
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start15 Apr 2020
- Primary completion14 Apr 2021 (estimated)
- Study completion14 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University Hopsital Schleswig Holstein Campus Lübeck, University Hospital Schleswig-Holstein
- Responsible party
- Sponsor
- Investigators
- Katja Weisel, MD, Principal investigator, University Medical Center of Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408339
- Sponsor's protocol ID
- PV7313
- Acronym
- COVIDHELP
- Status last verified
- Jun 2020
- First submitted
- 19 May 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Aggregated data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04408339
- Acronym / sponsor ID
- COVIDHELP / PV7313
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University Hopsital Schleswig Holstein Campus Lübeck, University Hospital Schleswig-Holstein
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 14 Apr 2021 (estimated)
- Study completion
- 14 Apr 2022 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Known diagnosis of cancer
- Known diagnosis of CoVID-19 infection
- Age ≥ 18 years
- Signed informed consent
Key exclusion criteria (1 listed)
- refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | – |
Primary outcome
Rate of hospitalization
Time frame: 2 years
Measured in percentage
Duration of hospitalization
Time frame: 2 years
Measured in days from date of admission to definitive discharge
Rate of admission to intensive care unit
Time frame: 2 years
Measured in percentage
Length of stay in intensive care unit
Time frame: 2 years
Measured in days from date of admission to intensive care unit to the date of discharge
Need of mechanical ventilation
Time frame: 2 years
Measured in percentage
Duration of mechanical ventilation
Time frame: 2 years
Measured in days from the date of intubation to the stop date of mechanical ventilation
Disease-specific mortality rate
Time frame: 2 years
COVID-19 associated mortality rate
2 secondary outcomes
Rate of patients, whose oncologic treatment had to be modified due to COVID-19
Time frame: 2 years
Cellular and humoral immune response to COVID-19 infection
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: Undecided. Aggregated data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Weisel, MD principal investigator
University Medical Center of Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and COVID, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katja Weisel, MD (+49407410 ext. 58787, k.weisel@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hospitalization (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.