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

NCT ID: NCT04771559

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-07-01

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.

Conditions

Covid19; Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cancer patients

Covid-19 antibody levels of patients will be measured

Group Type: OTHER

COVID-19 antibody test

Intervention Type: 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

Healthy control

Covid-19 antibody levels of healthy controls will be measured

Group Type: OTHER

COVID-19 antibody test

Intervention Type: 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

Interventions

COVID-19 antibody test

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

Intervention Type: OTHER

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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Ayşe İrem Yasin

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MAHMUT GUMUS, PROF

Role: STUDY_CHAIR

MEDENIYET UNIVERSITY

AHMET BILICI, PROF

Role: STUDY_CHAIR

Medipol University

HACI MEHMET TURK, PROF

Role: STUDY_CHAIR

BEZMIALEM UNIVERSITY

MESUT SEKER, PROF

Role: STUDY_DIRECTOR

BEZMIALEM UNIVERSITY

AYSE IREM YASIN, MD

Role: PRINCIPAL_INVESTIGATOR

BEZMIALEM UNIVERSITY

BILGE SUMBUL, ASOC.PROF.

Role: STUDY_CHAIR

BEZMIALEM UNIVERSITY

FAYSAL DANE, PROF

Role: STUDY_CHAIR

Acibadem University

CAGLAYAN GEREDELI, ASOC.PROF.

Role: STUDY_CHAIR

OKMEYDANI RESEARCH HOSPITAL

Locations

Bezmialem University

Istanbul, Fatih, Turkey (Türkiye)

Okmeydani Research Hospital

Istanbul, Fatih, Turkey (Türkiye)

Acibadem University

Istanbul, , Turkey (Türkiye)

Medeniyet University

Istanbul, , Turkey (Türkiye)

Medipol University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 35081732 (View on PubMed)

Other Identifiers

132620

Identifier Type: -

Identifier Source: org_study_id