Efficacy and Safety of COVID-19 Vaccine in Cancer Patients
NCT ID: NCT04865133
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
89 participants
OBSERVATIONAL
2021-03-31
2022-09-08
Brief Summary
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Detailed Description
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I. To determine the antibody response to COVID-19 vaccine after vaccination. II. To assess the adverse events of COVID-19 vaccines in cancer patients. III. To determine the incidence and severity of COVID-19 infection after the vaccination.
OUTLINE:
Patients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing.
Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Observational (biospecimen collection, medical record)
Patients undergo blood sample collection at baseline (prior to first COVID-19 vaccination), prior to second vaccination, 1, 6, and 12 months after the last vaccination. Patients receiving a booster vaccine will undergo blood collection prior to and 1-3 months after vaccination. Patients who receive the types of COVID-19 vaccines that do not require the second injection skip blood sample collection at this time point. This study will collect information regarding the type of COVID-19 vaccine received, date of vaccine injection, and any side effects associated with the COVID-19 vaccine that trial participant encountered. This study will also review the medical record for outcomes and information related to the blood testing.
Biospecimen Collection
Undergo blood sample collection
Electronic Health Record Review
Medical record reviewed
Interventions
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Biospecimen Collection
Undergo blood sample collection
Electronic Health Record Review
Medical record reviewed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide research blood samples
* Capable of providing valid informed consent
* For cancer patient cohort:
* Male or female age \>= 18 years
* Histologically confirmed solid malignancy on or will be starting on systemic cytotoxic chemotherapy
* For healthy individual cohort:
* Male or female age \>= 18 years
* No history of active malignancy =\< 3 years
* EXCEPTIONS: Adequately treated non-melanotic skin cancer (adequate wound healing is required prior to study entry) or carcinoma-in-situ of the cervix
* NOTE: If there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence =\< 3 years
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Willing and able to provide research blood samples
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Capable of providing valid informed consent
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Male or female age \>= 18 years
* PATIENTS WITH PREVIOUS COVID-19 INFECTION: Previous history of COVID-19 infection with positive SARS-CoV-2 ribonucleic acid (RNA) by polymerase chain reaction (PCR) or anti-SARS-CoV-2 nucleocapsid antibody
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Saranya Chumsri, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2021-03137
Identifier Type: REGISTRY
Identifier Source: secondary_id
21-001818
Identifier Type: -
Identifier Source: org_study_id