Clinical Trials Logo
  1. Home
  2. Cancer
  3. NCT04800146
  4. Details
NCT04800146 Clinical Trial

A Study on the Immune-response to COVID-19 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study

Cancer Clinical Trial

Official title:
A Prospective Observational Study on the Immune-response to SARS-CoV-2 Vaccination in Cancer Patients - the IOSI-COVID-19-001 Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04800146
Other study ID # IOSI-COVID19-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 25, 2021
Est. completion date March 21, 2023

Study information
Verified date March 2023
Source Oncology Institute of Southern Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 177
Est. completion date March 21, 2023
Est. primary completion date March 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sample
Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination

Locations
Country Name City State
Switzerland Oncology Institute of Southern Switzerland Bellinzona

Sponsors (3)
Lead Sponsor Collaborator
Ilaria Colombo Ente Ospedaliero Cantonale, Bellinzona, Institute for Research in Biomedicine

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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. 3, 6, 9 and 12 months following vaccination
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases