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

Bezmialem Vakif University1,500 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

1,500

Conditions

Covid19 Cancer

Interventions

COVID-19 antibody testOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: For the patient group : 1. Patients with pathological and clinical cancer diagnosis 2. Older than 18 years 3. Patients two doses of COVID-19 vaccine administered 4. Volunteering to participate in the study For the control group : 1. No known cancer diagnosis or history 2. Older than 18 years 3. Two doses of COVID-19 vaccine administered 4. Volunteering to participate in the study - Exclusion Criteria: 1. Not volunteering to participate in the study 2. \< 18 years 3. Not administered two doses of the COVID-19 vaccine 4. Covid-19 infection history -

Locations (5)

Bezmialem University

Istanbul, Fatih, Turkey (Türkiye)

Okmeydani Research Hospital

Istanbul, Fatih, Turkey (Türkiye)

Acibadem University

Istanbul, Turkey (Türkiye)

Medeniyet University

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Antibody levels

COVID-19 antibody titers of the patients will be measured in blood samples.

Time frame: 1 month

Secondary Outcomes

Side effects

Participants will be questioned for common side effects

Time frame: 1 month

Data from ClinicalTrials.gov

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