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| Name | Class |
|---|---|
| Institute for Research in Biomedicine | UNKNOWN |
| Ente Ospedaliero Cantonale, Bellinzona | OTHER |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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 |
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| 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. |
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| Cohort 4 | patients with previously untreated mature B cell tumors in watch and wait |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Procedure | Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3, 6, 9 and 12 months following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3, 6, 9 and 12 months following vaccination |
| Cellular immune response to SARS-CoV-2 vaccine |
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Inclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Southern Switzerland | Bellinzona | 6500 | Switzerland |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |
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| Cohort 7 | patients with hematological malignancies who have received autologous stem cell or allogenic transplant within 12 months |
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| Cohort 8 | non-cancer subjects (age and gender matched) referred to the Division of Infectious Diseases, Lugano, EOC for vaccination against SARS-CoV-2. |
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To explore the dynamic changes overtime of the T cells immune response following SARS-CoV-2 vaccination in cancer patients and controls. |
| 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. | 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) | 3, 6, 9 and 12 months following vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |