Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients
Primary Purpose
Covid19, Cancer
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
COVID-19 antibody test
Sponsored by
About this trial
This is an interventional other trial for Covid19 focused on measuring Cancer, Covid-19, Vaccine
Eligibility Criteria
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 -
Sites / Locations
- Bezmialem University
- Okmeydani Research Hospital
- Acibadem University
- Medeniyet University
- Medipol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Cancer patients
Healthy control
Arm Description
Covid-19 antibody levels of patients will be measured
Covid-19 antibody levels of healthy controls will be measured
Outcomes
Primary Outcome Measures
Antibody levels
COVID-19 antibody titers of the patients will be measured in blood samples.
Secondary Outcome Measures
Side effects
Participants will be questioned for common side effects
Full Information
NCT ID
NCT04771559
First Posted
February 17, 2021
Last Updated
August 1, 2021
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04771559
Brief Title
Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients
Official Title
Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Cancer
Keywords
Cancer, Covid-19, Vaccine
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
1500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cancer patients
Arm Type
Other
Arm Description
Covid-19 antibody levels of patients will be measured
Arm Title
Healthy control
Arm Type
Other
Arm Description
Covid-19 antibody levels of healthy controls will be measured
Intervention Type
Other
Intervention Name(s)
COVID-19 antibody test
Intervention Description
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 Measure Information:
Title
Antibody levels
Description
COVID-19 antibody titers of the patients will be measured in blood samples.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Side effects
Description
Participants will be questioned for common side effects
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MAHMUT GUMUS, PROF
Organizational Affiliation
MEDENIYET UNIVERSITY
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
AHMET BILICI, PROF
Organizational Affiliation
Medipol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
HACI MEHMET TURK, PROF
Organizational Affiliation
BEZMIALEM UNIVERSITY
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
MESUT SEKER, PROF
Organizational Affiliation
BEZMIALEM UNIVERSITY
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
AYSE IREM YASIN, MD
Organizational Affiliation
BEZMIALEM UNIVERSITY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BILGE SUMBUL, ASOC.PROF.
Organizational Affiliation
BEZMIALEM UNIVERSITY
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
FAYSAL DANE, PROF
Organizational Affiliation
Acibadem University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
CAGLAYAN GEREDELI, ASOC.PROF.
Organizational Affiliation
OKMEYDANI RESEARCH HOSPITAL
Official's Role
Study Chair
Facility Information:
Facility Name
Bezmialem University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34090
Country
Turkey
Facility Name
Okmeydani Research Hospital
City
Istanbul
State/Province
Fatih
Country
Turkey
Facility Name
Acibadem University
City
Istanbul
Country
Turkey
Facility Name
Medeniyet University
City
Istanbul
Country
Turkey
Facility Name
Medipol University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35081732
Citation
Yasin AI, Aydin SG, Sumbul B, Koral L, Simsek M, Geredeli C, Ozturk A, Perkin P, Demirtas D, Erdemoglu E, Hacibekiroglu I, Cakir E, Tanrikulu E, Coban E, Ozcelik M, Celik S, Teker F, Aksoy A, Firat ST, Tekin O, Kalkan Z, Turken O, Oven BB, Dane F, Bilici A, Isikdogan A, Seker M, Turk HM, Gumus M. Efficacy and safety profile of COVID-19 vaccine in cancer patients: a prospective, multicenter cohort study. Future Oncol. 2022 Mar;18(10):1235-1244. doi: 10.2217/fon-2021-1248. Epub 2022 Jan 27.
Results Reference
derived
Learn more about this trial
Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients
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