Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800146
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2021-03-10
Brief Title:
A Study on the Immune-response to COVID-19 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
Sponsor:
Ilaria Colombo
Organization:
Oncology Institute of Southern Switzerland
Study Overview
Official Title:
A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None