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

Bezmialem Vakif University

Status: Completed

Conditions: Covid19; Cancer

Treatments: Other: COVID-19 antibody test

Study type: Interventional

Funder types: Other

Identifiers

NCT04771559

132620

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Cancer patients

Other group

Description:

Covid-19 antibody levels of patients will be measured

Treatment:

Other: COVID-19 antibody test

Healthy control

Other group

Description:

Covid-19 antibody levels of healthy controls will be measured

Treatment:

Other: COVID-19 antibody test