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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer patients | Other | Covid-19 antibody levels of patients will be measured |
|
| Healthy control | Other | Covid-19 antibody levels of healthy controls will be measured |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 antibody test | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody levels | COVID-19 antibody titers of the patients will be measured in blood samples. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Participants will be questioned for common side effects | 1 month |
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Inclusion Criteria:
For the patient group :
For the control group :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MAHMUT GUMUS, PROF | MEDENIYET UNIVERSITY | Study Chair |
| AHMET BILICI, PROF | Medipol University | Study Chair |
| HACI MEHMET TURK, PROF | BEZMIALEM UNIVERSITY | Study Chair |
| MESUT SEKER, PROF | BEZMIALEM UNIVERSITY | Study Director |
| AYSE IREM YASIN, MD | BEZMIALEM UNIVERSITY | Principal Investigator |
| BILGE SUMBUL, ASOC.PROF. | BEZMIALEM UNIVERSITY | Study Chair |
| FAYSAL DANE, PROF | Acibadem University | Study Chair |
| CAGLAYAN GEREDELI, ASOC.PROF. | OKMEYDANI RESEARCH HOSPITAL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem University | Istanbul | Fatih | 34090 | Turkey (Türkiye) | ||
| Okmeydani Research Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35081732 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000087124 | COVID-19 Serological Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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|
| Istanbul |
| Fatih |
| Turkey (Türkiye) |
| Acibadem University | Istanbul | Turkey (Türkiye) |
| Medeniyet University | Istanbul | Turkey (Türkiye) |
| Medipol University | Istanbul | Turkey (Türkiye) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012698 | Serologic Tests |
| D007159 | Immunologic Tests |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |