Covid19NCT04800146
A Study on the Immune-response to COVID-19 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
An observational study of Covid19 and Cancer, run by Ilaria Colombo at 1 site in Switzerland.
Trial summary
This is a single centre prospective observational study to assess the immune response to SARS-CoV-2 vaccines in cancer patients receiving active treatment or in follow-up at the IOSI and in non-cancer patients (age and gender matched). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Blood sample
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 177 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Feb 2021to 21 Mar 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population of this study is represented by patients with a diagnosis of solid tumor or hematological malignancy and receiving treatment or on active surveillance at the IOSI who have planned to receive an mRNA (messenger ribonucleic acid) SARS-CoV-2 vaccine, according to the prespecified cohorts. A control group of non-cancer subjects followed at the outpatient clinic of the Division of Infectious Diseases, EOC will also be enrolled for comparative analysis.
Who may be able to join
- Male of Female age at least 18 years
- Patients with a diagnosis of malignancy (solid tumors or hematological malignancies) according to the defined cohorts. Only for cohorts 1-7
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Absence of known immune deficiency (other than cancer for cohorts 1-7)
- Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
- Willing and able to comply with the study procedures.
- Willing to receive an mRNA anti-SARS-CoV-2 vaccine.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Oncology Institute of Southern Switzerland
Bellinzona, 6500
About this study
Official title: A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
This is a single centre prospective observational study to assess the immune response to SARS-CoV-2 vaccines in cancer patients receiving active treatment or in follow-up at the IOSI and in non-cancer patients (age and gender matched).
Read the detailed description
This study will be conducted on 7 cohorts of cancer patients and 1 cohort of non-cancer subjects (age and gender matched) with a sample size of 30 patients in each cohort:
All enrolled patients will be asked to provide blood samples (2 x 10cc Heparin Tubes) at the following time points:
- Baseline: before the administration of the first dose of the SARS-CoV-2 vaccine (within 4 weeks).
- Before the second dose of the SARS-CoV-2 vaccine (within 7 days).
- Follow-up: after 3, 6, 9 and 12 months after the second dose of the SARS-CoV-2 vaccine. A +/- 14 days window is allowed at each follow-up time point.
- Being tested
- Blood sample
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | patients with solid tumors treated with chemotherapy (ongoing or completed no more than 6 months before enrollment). Specific type of chemotherapy inducing similar immunosuppression will be selected (including but not limited to platinum-based combinations, anthracycline combinations, triweekly docetaxel). Receives: Procedure: Blood sample | |
| Cohort 2 | patients with solid tumors treated with single agent immune-check points inhibitors (ongoing or completed no more than 6 months before the enrollment Receives: Procedure: Blood sample | |
| Cohort 3 | patients with solid tumors treated with hormonal agents (ongoing or completed no more than 6 months before enrollment): any anti-androgen for prostate cancer and any anti-estrogen for breast cancer patients. Receives: Procedure: Blood sample | |
| Cohort 4 | patients with previously untreated mature B cell tumors in watch and wait Receives: Procedure: Blood sample | |
| Cohort 5 | patients with mature B cell tumors treated with anti-CD20 monoclonal antibody either alone or in combination with chemotherapy (ongoing or completed no more than 12 months before enrollment Receives: Procedure: Blood sample | |
| Cohort 6 | patients with hematological malignancies treated with pathway inhibitors (ongoing or completed no more than 12 months before enrollment). Different type of targeted agents can be considered, including Bruton tyrosine kinase (BTK) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors or phosphoinositide-3 kinase (PI3K) inhibitors Receives: Procedure: Blood sample | |
| Cohort 7 | patients with hematological malignancies who have received autologous stem cell or allogenic transplant within 12 months Receives: Procedure: Blood sample | |
| Cohort 8 | non-cancer subjects (age and gender matched) referred to the Division of Infectious Diseases, Lugano, EOC for vaccination against SARS-CoV-2. Receives: Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response to SARS-CoV-2 vaccine in cancer patients
to determine the changes in the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens in 7 cohorts of cancer patients who have received the SARS-CoV-2 vaccination. A cohort of non-cancer subjects will be used as control group.
Measured: 3, 6, 9 and 12 months following vaccination
Secondary outcomes (4)
changes in serum antibodies anti SARS-CoV-2 after vaccination
To explore the dynamic changes overtime of the levels of antibodies against SARS-CoV-2 following vaccination in cancer patients and controls
Measured: 3, 6, 9 and 12 months following vaccination
Cellular immune response to SARS-CoV-2 vaccine
To explore the dynamic changes overtime of the T cells immune response following SARS-CoV-2 vaccination in cancer patients and controls.
Measured: 3, 6, 9 and 12 months following vaccination
Cellular immune response to SARS-CoV-2 vaccine
To explore the dynamic changes overtime of the B cells immune response following SARS-CoV-2 vaccination in cancer patients and controls.
Measured: 3, 6, 9 and 12 months following vaccination
Immune response to SARS-CoV-2 vaccine according tumor and treatment type
To explore the correlation between the immune response against SARS-CoV-2 vaccination and the type of cancer (e.g., solid tumors versus hematological malignancies) and the type of anticancer treatment (e.g., anti-CD20, chemotherapy, targeted agents, immunotherapy, allogenic or autologous transplant)
Measured: 3, 6, 9 and 12 months following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start25 Feb 2021
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 only
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilaria Colombo
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Research in Biomedicine, Ente Ospedaliero Cantonale, Bellinzona
- Responsible party
- Sponsor-investigator, Ilaria Colombo, Oncology Institute of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800146
- Sponsor's protocol ID
- IOSI-COVID19-001
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
- ClinicalTrials.gov ID
- NCT04800146
- Acronym / sponsor ID
- IOSI-COVID19-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Ilaria ColomboUniversity, hospital or other
- Collaborators
- Institute for Research in Biomedicine, Ente Ospedaliero Cantonale, Bellinzona
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 16 Mar 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 a single centre prospective observational study to assess the immune response to SARS-CoV-2 vaccines in cancer patients receiving active treatment or in follow-up at the IOSI and in non-cancer patients (age and gender matched).
Detailed description
This study will be conducted on 7 cohorts of cancer patients and 1 cohort of non-cancer subjects (age and gender matched) with a sample size of 30 patients in each cohort:
All enrolled patients will be asked to provide blood samples (2 x 10cc Heparin Tubes) at the following time points:
- Baseline: before the administration of the first dose of the SARS-CoV-2 vaccine (within 4 weeks).
- Before the second dose of the SARS-CoV-2 vaccine (within 7 days).
- Follow-up: after 3, 6, 9 and 12 months after the second dose of the SARS-CoV-2 vaccine. A +/- 14 days window is allowed at each follow-up time point.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Procedure: Blood samplepatients with solid tumors treated with chemotherapy (ongoing or completed no more than 6 months before enrollment). Specific type of chemotherapy inducing similar immunosuppression will be selected (including but not limited to platinum-based combinations, anthracycline combinations, triweekly docetaxel). |
| Cohort 2 | – | Procedure: Blood samplepatients with solid tumors treated with single agent immune-check points inhibitors (ongoing or completed no more than 6 months before the enrollment |
| Cohort 3 | – | Procedure: Blood samplepatients with solid tumors treated with hormonal agents (ongoing or completed no more than 6 months before enrollment): any anti-androgen for prostate cancer and any anti-estrogen for breast cancer patients. |
| Cohort 4 | – | Procedure: Blood samplepatients with previously untreated mature B cell tumors in watch and wait |
| Cohort 5 | – | Procedure: Blood samplepatients with mature B cell tumors treated with anti-CD20 monoclonal antibody either alone or in combination with chemotherapy (ongoing or completed no more than 12 months before enrollment |
| Cohort 6 | – | Procedure: Blood samplepatients with hematological malignancies treated with pathway inhibitors (ongoing or completed no more than 12 months before enrollment). Different type of targeted agents can be considered, including Bruton tyrosine kinase (BTK) inhibitors, B-cell lymphoma 2 (BCL-2) inhibitors or phosphoinositide-3 kinase (PI3K) inhibitors |
| Cohort 7 | – | Procedure: Blood samplepatients with hematological malignancies who have received autologous stem cell or allogenic transplant within 12 months |
| Cohort 8 | – | Procedure: Blood samplenon-cancer subjects (age and gender matched) referred to the Division of Infectious Diseases, Lugano, EOC for vaccination against SARS-CoV-2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of this study is represented by patients with a diagnosis of solid tumor or hematological malignancy and receiving treatment or on active surveillance at the IOSI who have planned to receive an mRNA (messenger ribonucleic acid) SARS-CoV-2 vaccine, according to the prespecified cohorts. A control group of non-cancer subjects followed at the outpatient clinic of the Division of Infectious Diseases, EOC will also be enrolled for comparative analysis.
Key inclusion criteria (7 listed)
- Male of Female age at least 18 years
- Patients with a diagnosis of malignancy (solid tumors or hematological malignancies) according to the defined cohorts. Only for cohorts 1-7
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Absence of known immune deficiency (other than cancer for cohorts 1-7)
- Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blood samplePatients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination | Procedure or surgery | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
Primary outcome
Immune response to SARS-CoV-2 vaccine in cancer patients
Time frame: 3, 6, 9 and 12 months following vaccination
to determine the changes in the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens in 7 cohorts of cancer patients who have received the SARS-CoV-2 vaccination. A cohort of non-cancer subjects will be used as control group.
4 secondary outcomes
changes in serum antibodies anti SARS-CoV-2 after vaccination
Time frame: 3, 6, 9 and 12 months following vaccination
Cellular immune response to SARS-CoV-2 vaccine
Time frame: 3, 6, 9 and 12 months following vaccination
Cellular immune response to SARS-CoV-2 vaccine
Time frame: 3, 6, 9 and 12 months following vaccination
Immune response to SARS-CoV-2 vaccine according tumor and treatment type
Time frame: 3, 6, 9 and 12 months following vaccination
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 23 Mar 2023.
- Individual participant dataSharing planned: No
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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 Covid19 and Cancer, run by Ilaria Colombo at 1 site in Switzerland.
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 7 inclusion and 0 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 23 Mar 2023. 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 Switzerland. 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?
Immune response to SARS-CoV-2 vaccine in cancer patients (time frame: 3, 6, 9 and 12 months following vaccination). 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 23 Mar 2023.