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

Not Applicable

Completed

• Conditions: Covid19; Cancer
• Interventions: Other: COVID-19 antibody test

• Registration Number: NCT04771559
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Study Start: 2021-03-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-07-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-01
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cancer patients	COVID-19 antibody test	Covid-19 antibody levels of patients will be measured
Healthy control	COVID-19 antibody test	Covid-19 antibody levels of healthy controls will be measured

Primary Outcome Measures

Name	Time	Method
Antibody levels	1 month	COVID-19 antibody titers of the patients will be measured in blood samples.

Secondary Outcome Measures

Name	Time	Method
Side effects	1 month	Participants will be questioned for common side effects

Trial Locations

Locations (5)

Bezmialem University; 🇹🇷 Istanbul, Fatih, Turkey

Acibadem University; 🇹🇷 Istanbul, Turkey

Medipol University; 🇹🇷 Istanbul, Turkey

Medeniyet University; 🇹🇷 Istanbul, Turkey

Okmeydani Research Hospital; 🇹🇷 Istanbul, Fatih, Turkey