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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

About this trial

This is an interventional other trial for Covid19 focused on measuring Cancer, Covid-19, Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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: