A Study on the Immune-response to COVID-19 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
1 other identifier
observational
177
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2021
CompletedFirst Submitted
Initial submission to the registry
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2023
CompletedMarch 23, 2023
March 1, 2023
2.1 years
March 10, 2021
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
changes in serum antibodies anti SARS-CoV-2 after vaccination
3, 6, 9 and 12 months following vaccination
Cellular immune response to SARS-CoV-2 vaccine
3, 6, 9 and 12 months following vaccination
Cellular immune response to SARS-CoV-2 vaccine
3, 6, 9 and 12 months following vaccination
Immune response to SARS-CoV-2 vaccine according tumor and treatment type
3, 6, 9 and 12 months following vaccination
Study Arms (8)
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).
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
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.
Cohort 4
patients with previously untreated mature B cell tumors in watch and wait
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
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
Cohort 7
patients with hematological malignancies who have received autologous stem cell or allogenic transplant within 12 months
Cohort 8
non-cancer subjects (age and gender matched) referred to the Division of Infectious Diseases, Lugano, EOC for vaccination against SARS-CoV-2.
Interventions
Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination
Eligibility Criteria
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.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ilaria Colombolead
- Institute for Research in Biomedicinecollaborator
- Ente Ospedaliero Cantonale, Bellinzonacollaborator
Study Sites (1)
Oncology Institute of Southern Switzerland
Bellinzona, 6500, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 10, 2021
First Posted
March 16, 2021
Study Start
February 25, 2021
Primary Completion
March 21, 2023
Study Completion
March 21, 2023
Last Updated
March 23, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share