Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effects and side effects of inactive COVID-19 vaccine in patients with cancer and compare them with the healthy control group.

Detailed Description
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The aim of the study is to evaluate the effects and side effects of inactive COVID-19 vaccine in patients with cancer. Patients followed up in medical oncology clinic and healthy volunteers will be enrolled in the study. Blood samples of participants will be taken 4 weeks after the second dose of the COVID-19 vaccine. After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different eppendorf tubes and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples. In addition, volunteers will be questioned in terms of side effects that may develop after vaccination and the information obtained will be recorded in the database together with the clinical data of the patients.

Official Title
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Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients

Conditions
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Covid19, Cancer

Intervention / Treatment
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* Other: COVID-19 antibody test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the patient group : Patients with pathological and clinical cancer diagnosis Older than 18 years Patients two doses of COVID-19 vaccine administered Volunteering to participate in the study For the control group : No known cancer diagnosis or history Older than 18 years Two doses of COVID-19 vaccine administered Volunteering to participate in the study - Exclusion Criteria: Not volunteering to participate in the study < 18 years Not administered two doses of the COVID-19 vaccine Covid-19 infection history -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study consists of two groups : 1) Cancer patients, 2) Healthy controls Blood samples will be taken from the participants of the two groups 4 weeks after the second dose of the COVID-19 vaccine and antibody testing will be performed. Additionally participants will be questioned for side effects of the vaccine and the data will be registered.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cancer patients<br>Covid-19 antibody levels of patients will be measured | Other: COVID-19 antibody test<br>* 5 cc blood sample from each participant will be taken 4 weeks after the second dose of the COVID-19 vaccine . After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different ependorphs and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples<br>|
| Other: Healthy control<br>Covid-19 antibody levels of healthy controls will be measured | Other: COVID-19 antibody test<br>* 5 cc blood sample from each participant will be taken 4 weeks after the second dose of the COVID-19 vaccine . After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different ependorphs and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody levels | COVID-19 antibody titers of the patients will be measured in blood samples. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Participants will be questioned for common side effects | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Covid-19, Vaccine