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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04771559
Enrollment
1500
Registered
2021-02-25
Start date
2021-03-01
Completion date
2021-07-01
Last updated
2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Covid19

Keywords

Cancer, Covid-19, Vaccine

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.

Interventions

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

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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 -

Design outcomes

Primary

MeasureTime frameDescription
Antibody levels1 monthCOVID-19 antibody titers of the patients will be measured in blood samples.

Secondary

MeasureTime frameDescription
Side effects1 monthParticipants will be questioned for common side effects

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026