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

August 1, 2021 updated by: Ayşe İrem Yasin, Bezmialem Vakif University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Medipol University
      • Istanbul, Turkey
        • Acibadem University
      • Istanbul, Turkey
        • Medeniyet University
    • Fatih
      • Istanbul, Fatih, Turkey, 34090
        • Bezmialem University
      • Istanbul, Fatih, Turkey
        • Okmeydani Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cancer patients
Covid-19 antibody levels of patients will be measured
Other: COVID-19 antibody test
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
Other: Healthy control
Covid-19 antibody levels of healthy controls will be measured
Other: COVID-19 antibody test
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody levels
Time Frame: 1 month
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
Time Frame: 1 month
Participants will be questioned for common side effects
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Study Chair: MAHMUT GUMUS, PROF, Medeniyet University
  • Study Chair: AHMET BILICI, PROF, Medipol University
  • Study Chair: HACI MEHMET TURK, PROF, Bezmialem University
  • Study Director: MESUT SEKER, PROF, Bezmialem University
  • Principal Investigator: AYSE IREM YASIN, MD, Bezmialem University
  • Study Chair: BILGE SUMBUL, ASOC.PROF., Bezmialem University
  • Study Chair: FAYSAL DANE, PROF, Acibadem University
  • Study Chair: CAGLAYAN GEREDELI, ASOC.PROF., Okmeydani Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 1, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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