Clinical trial NCT04771559: 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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Cancer
Keywords: Cancer, Covid-19, Vaccine
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility 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 -

Primary outcomes:
measure: Antibody levels
timeFrame: 1 month
Secondary outcomes:
measure: Side effects
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem University
state: Fatih
city: Istanbul
country: Turkey
facility: Okmeydani Research Hospital
state: Fatih
city: Istanbul
country: Turkey
facility: Acibadem University
city: Istanbul
country: Turkey
facility: Medeniyet University
city: Istanbul
country: Turkey
facility: Medipol University
Study officials:
affiliation: MEDENIYET UNIVERSITY
name: MAHMUT GUMUS, PROF
role: STUDY_CHAIR
affiliation: Medipol University
name: AHMET BILICI, PROF
role: STUDY_CHAIR
affiliation: BEZMIALEM UNIVERSITY
name: HACI MEHMET TURK, PROF
role: STUDY_CHAIR
affiliation: BEZMIALEM UNIVERSITY
name: MESUT SEKER, PROF
role: STUDY_DIRECTOR
affiliation: BEZMIALEM UNIVERSITY
name: AYSE IREM YASIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BEZMIALEM UNIVERSITY
name: BILGE SUMBUL, ASOC.PROF.
role: STUDY_CHAIR
affiliation: Acibadem University
name: FAYSAL DANE, PROF
role: STUDY_CHAIR
affiliation: OKMEYDANI RESEARCH HOSPITAL
name: CAGLAYAN GEREDELI, ASOC.PROF.
role: STUDY_CHAIR
References:
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.