An observational study in Covid19 and Cancer, sponsored by Ilaria Colombo. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Ilaria Colombo · Observational
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:
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 177 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Ilaria Colombo as lead sponsor.
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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.
Inclusion Criteria:
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).
Procedure: Blood sample
patients with solid tumors treated with single agent immune-check points inhibitors (ongoing or completed no more than 6 months before the enrollment
Procedure: Blood sample
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.
Procedure: Blood sample
patients with previously untreated mature B cell tumors in watch and wait
Procedure: Blood sample
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
Procedure: Blood sample
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
Procedure: Blood sample
patients with hematological malignancies who have received autologous stem cell or allogenic transplant within 12 months
Procedure: Blood sample
non-cancer subjects (age and gender matched) referred to the Division of Infectious Diseases, Lugano, EOC for vaccination against SARS-CoV-2.
Procedure: Blood sample
Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination
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.
Time frame: 3, 6, 9 and 12 months following vaccination
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
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 3, 6, 9 and 12 months following vaccination
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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