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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04771559
Recruitment Status : Completed
First Posted : February 25, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Ayşe İrem Yasin, 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.

Condition or disease Intervention/treatment Phase
Covid19 Cancer Other: COVID-19 antibody test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study consists of two groups : 1) Cancer patients, 2) Healthy controls Blood samples will be taken from the participants of the two groups 4 weeks after the second dose of the COVID-19 vaccine and antibody testing will be performed. Additionally participants will be questioned for side effects of the vaccine and the data will be registered.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients
Actual Study Start Date : March 1, 2021
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Antibody levels [ Time Frame: 1 month ]
    COVID-19 antibody titers of the patients will be measured in blood samples.


Secondary Outcome Measures :
  1. Side effects [ Time Frame: 1 month ]
    Participants will be questioned for common side effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771559


Locations
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Turkey
Bezmialem University
Istanbul, Fatih, Turkey, 34090
Okmeydani Research Hospital
Istanbul, Fatih, Turkey
Acibadem University
Istanbul, Turkey
Medeniyet University
Istanbul, Turkey
Medipol University
Istanbul, Turkey
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ayşe İrem Yasin, MD, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04771559    
Other Study ID Numbers: 132620
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayşe İrem Yasin, Bezmialem Vakif University:
Cancer, Covid-19, Vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs