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

NCT04771559 | Completed DMC

• 1 other identifier: 132620
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 5

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.

Conditions

Covid19; Cancer

Keywords

Cancer, Covid-19, Vaccine

Outcome Measures

Primary Outcomes (1)

• Antibody levels

  COVID-19 antibody titers of the patients will be measured in blood samples.

  1 month

Secondary Outcomes (1)

• Side effects

  1 month

Study Arms (2)

Cancer patients

OTHER

Covid-19 antibody levels of patients will be measured

Other: COVID-19 antibody test

Healthy control

OTHER

Covid-19 antibody levels of healthy controls will be measured

Other: COVID-19 antibody test

Interventions

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

Cancer patients; Healthy control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• Not volunteering to participate in the study
• \< 18 years
• Not administered two doses of the COVID-19 vaccine
• Covid-19 infection history -

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (5)

Bezmialem University

Istanbul, Fatih, 34090, Turkey (Türkiye)

Location

Okmeydani Research Hospital

Istanbul, Fatih, Turkey (Türkiye)

Location

Acibadem University

Istanbul, Turkey (Türkiye)

Location

Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35081732 DERIVED

MeSH Terms

Conditions

COVID-19; Neoplasms

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Serologic Tests; Immunologic Tests; Investigative Techniques; Immunologic Techniques

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 25, 2021
• Study Start: March 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (5)