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OpenTrials
Completed

NCT Number: NCT04771559

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem University, Istanbul, Fatih, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

COVID-19 antibody test

Other

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

Primary outcomes

  1. Antibody levels

    Time frame: 1 month

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

Secondary outcomes

  1. Side effects

    Time frame: 1 month

    Participants will be questioned for common side effects

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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