CancerReCOVerNCT04745377
Responses to COVID-19 Vaccination in Patients With Cancer
An observational study of Cancer, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
Trial summary
This is an observational study that will prospectively record and monitor responses and clinical outcomes of patients with cancer after covid-19 vaccination, including measurements of antibody titers in serum and also record potential factors that affect immunity, such as type and stage of cancer, type and time of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus
- Type of treatment
- Vaccines
- How many people
- 332 participants
- Where
- 1 siteGreece
- Study dates
- 12 Jan 2021to 20 May 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with solid tumours and potentially immunocompromised, ie. currently with active disease and/or undergoing active antineoplastic therapy of any type (chemotherapy, immunotherapy, biologic therapy, targeted therapy) that will be vaccinated for covid-19 within the National Program of Vaccination. Also a group of healthy volunteers from the hospital personnel that have been vaccinated within the National Program of Vaccination and signed informed consent for 3 measurements of antibody titers in serum, at the timepoints described aboved.
Who may be able to join
- Patients with solid tumours and potentially immunocompromised, ie. currently with active disease and/or undergoing active antineoplastic therapy of any type (chemotherapy, immunotherapy, biologic therapy, targeted therapy) that will be vaccinated for covid-19 within the National Program of Vaccination
- patients must sign informed consent for their data monitoring and also for serum antibody titers to covid-19 vaccination measured in three timepoints, prior to 1st dose and 1 and 3 months post completion of two doses
Who cannot join
- patients with haematological malignancies are excluded
- patients with prior diagnosis of cancer and now on follow-up without active disease are excluded
- patients on adjuvant hormonal therapy are excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mapping the Responses to COVID-19 Vaccination in Patients With Cancer - the ReCOVer Study
This is an observational study that will prospectively record and monitor responses and clinical outcomes of patients with cancer after covid-19 vaccination, including measurements of antibody titers in serum and also record potential factors that affect immunity, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.
Read the detailed description
It is well recognised that patients with cancer are at an increased risk of severe COVID-19 disease and should be at high prioritisation for vaccination against SARS-CoV-2. In Greece the vaccination of healthcare workers has been initiated in January 2021, elderly citizens as well and for cancer patients of all ages will be initiated early February 2021. There are very little available data on the efficacy of immunisation with vaccines overall in cancer patients, with most existing data involving the influenza vaccine. The covid-19 vaccine trials have not included cancer patients, therefore, the efficacy and duration of immunity in patients with cancer are still unknown. Those patients are often immunocompromised due to their disease or the side-effects of their treatment.
Based on the above this study was designed to prospectively record and monitor patients with cancer after covid-19 vaccination. The study will record and measure clinical outcomes, such as possible infection from covid-19 despite vaccination, severity and mortality, but also possible side effects post vaccination. Within the study serological responses (IgG antibody titers) will also be monitored in three timepoints (prior to vaccination, one month and three months after completion of the two doses of vaccination). Potential factors that affect immunity, will be recorded, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.
- Conditions
- Cancer
- Being tested
- IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus
- Keywords
- COVID-19 vaccination, Cancer patients, Immunity
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virusDiagnostic test
IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Healthy volunteers from hospital personnel vaccinated for covid-19, who sign informed consent for recording of outcomes and monitor of antibody titers in 3 timepoints Receives: Diagnostic Test: IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus | |
| Cancer patients | Cancer patients with solid tumours, with active disease and/or undergoing active systemic treatment, who will be vaccinated for covid-19 Receives: Diagnostic Test: IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome post vaccination
The primary outcome is the rate of COVID-19 infections post vaccination in cancer patients compared to individuals without cancer, measured as confirmed COVID-19 infections by positive PCR COVID-tests (in asymptomatic or symptomatic cases within a period of up to 12 months post vaccination)
Measured: 12 months
Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 1 month after completion of vaccination
This primary outcome includes the antibody based immune response to COVID-19 vaccination measured 1 month after the complete vaccination (2 doses) in patients with cancer as compared to individuals without cancer, expressed as antibody titres by means of ELISA
Measured: 1 month
Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 3 months after completion of vaccination
This outcome involves the persistence of antibody response to COVID-19 vaccination measured 3 months after the complete vaccination (2 doses) in patients with cancer as compared to individuals without cancer, expressed as antibody titres by means of ELISA
Measured: 3 months
Secondary outcomes (2)
Safety and Tolerance assessment - AEs; Incidence and severity of Adverse Events post vaccination
Incidence and severity of AEs post vaccination, with incidence and nature of AEs reported after each vaccination dose and up to 12 months post vaccination. The number of participants with adverse events and the severity of adverse events will be recorded as assessed by CTCAE v4.0.
Measured: 12 months
Correlation of factors that might affect immune response in patients with cancer compared to individuals without cancer
Correlation of factors (such as level of White Blood Count and Neutrophil Count prior to vaccination, type of cancer, type of cancer treatment, age and comorbidities) to the level of antibody response mounted post vaccination in patients with cancer. Age-adjusted comparisons with the group of individuals without cancer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start12 Jan 2021
- Primary completion14 Oct 2021
- Study completion20 May 2022
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745377
- Sponsor's protocol ID
- HE_42C/21 ReCOVer study
- Acronym
- ReCOVer
- Status last verified
- Aug 2022
- First submitted
- 15 Jan 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Responses to COVID-19 Vaccination in Patients With Cancer - the ReCOVer Study
- ClinicalTrials.gov ID
- NCT04745377
- Acronym / sponsor ID
- ReCOVer / HE_42C/21 ReCOVer study
- Conditions
- Cancer
- Keywords
- COVID-19 vaccination, Cancer patients, Immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 9 Feb 2021 (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.
This is an observational study that will prospectively record and monitor responses and clinical outcomes of patients with cancer after covid-19 vaccination, including measurements of antibody titers in serum and also record potential factors that affect immunity, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.
Detailed description
It is well recognised that patients with cancer are at an increased risk of severe COVID-19 disease and should be at high prioritisation for vaccination against SARS-CoV-2. In Greece the vaccination of healthcare workers has been initiated in January 2021, elderly citizens as well and for cancer patients of all ages will be initiated early February 2021. There are very little available data on the efficacy of immunisation with vaccines overall in cancer patients, with most existing data involving the influenza vaccine. The covid-19 vaccine trials have not included cancer patients, therefore, the efficacy and duration of immunity in patients with cancer are still unknown. Those patients are often immunocompromised due to their disease or the side-effects of their treatment.
Based on the above this study was designed to prospectively record and monitor patients with cancer after covid-19 vaccination. The study will record and measure clinical outcomes, such as possible infection from covid-19 despite vaccination, severity and mortality, but also possible side effects post vaccination. Within the study serological responses (IgG antibody titers) will also be monitored in three timepoints (prior to vaccination, one month and three months after completion of the two doses of vaccination). Potential factors that affect immunity, will be recorded, such as type and stage of cancer, type and time of systemic therapy in relation to covid-19 vaccination.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Diagnostic Test: IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virusHealthy volunteers from hospital personnel vaccinated for covid-19, who sign informed consent for recording of outcomes and monitor of antibody titers in 3 timepoints |
| Cancer patients | – | Diagnostic Test: IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virusCancer patients with solid tumours, with active disease and/or undergoing active systemic treatment, who will be vaccinated for covid-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid tumours and potentially immunocompromised, ie. currently with active disease and/or undergoing active antineoplastic therapy of any type (chemotherapy, immunotherapy, biologic therapy, targeted therapy) that will be vaccinated for covid-19 within the National Program of Vaccination. Also a group of healthy volunteers from the hospital personnel that have been vaccinated within the National Program of Vaccination and signed informed consent for 3 measurements of antibody titers in serum, at the timepoints described aboved.
Key inclusion criteria (2 listed)
- Patients with solid tumours and potentially immunocompromised, ie. currently with active disease and/or undergoing active antineoplastic therapy of any type (chemotherapy, immunotherapy, biologic therapy, targeted therapy) that will be vaccinated for covid-19 within the National Program of Vaccination
- patients must sign informed consent for their data monitoring and also for serum antibody titers to covid-19 vaccination measured in three timepoints, prior to 1st dose and 1 and 3 months post completion of two doses
Key exclusion criteria (3 listed)
- patients with haematological malignancies are excluded
- patients with prior diagnosis of cancer and now on follow-up without active disease are excluded
- patients on adjuvant hormonal therapy are excluded
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 |
|---|---|---|
| IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virusIgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus | Diagnostic test | Cancer patients, Control Group |
Primary outcome
Clinical outcome post vaccination
Time frame: 12 months
The primary outcome is the rate of COVID-19 infections post vaccination in cancer patients compared to individuals without cancer, measured as confirmed COVID-19 infections by positive PCR COVID-tests (in asymptomatic or symptomatic cases within a period of up to 12 months post vaccination)
Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 1 month after completion of vaccination
Time frame: 1 month
This primary outcome includes the antibody based immune response to COVID-19 vaccination measured 1 month after the complete vaccination (2 doses) in patients with cancer as compared to individuals without cancer, expressed as antibody titres by means of ELISA
Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 3 months after completion of vaccination
Time frame: 3 months
This outcome involves the persistence of antibody response to COVID-19 vaccination measured 3 months after the complete vaccination (2 doses) in patients with cancer as compared to individuals without cancer, expressed as antibody titres by means of ELISA
2 secondary outcomes
Safety and Tolerance assessment - AEs; Incidence and severity of Adverse Events post vaccination
Time frame: 12 months
Correlation of factors that might affect immune response in patients with cancer compared to individuals without cancer
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 17 Aug 2022. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome post vaccination (time frame: 12 months). The study lists 3 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 17 Aug 2022.