Covid19NCT04771559
Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients
A study testing COVID-19 antibody test in people with Covid19 and Cancer, run by Bezmialem Vakif University at 5 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- COVID-19 antibody test
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
Show all 10Show fewer
- No known cancer diagnosis or history
- Older than 18 years
- Two doses of COVID-19 vaccine administered
- Volunteering to participate in the study -
Who cannot join
- Not volunteering to participate in the study
- < 18 years
- Not administered two doses of the COVID-19 vaccine
- Covid-19 infection history -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Turkey (Türkiye)5 sites
Bezmialem University
Istanbul, Fatih, 34090
Okmeydani Research Hospital
Istanbul, Fatih
Acibadem University
Istanbul
Medeniyet University
Istanbul
Medipol University
Istanbul
About this study
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.
Read the 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.
- Being tested
- COVID-19 antibody test
- Keywords
- Cancer, Covid-19, Vaccine
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 antibody testOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Other | Covid-19 antibody levels of patients will be measured Receives: Other: COVID-19 antibody test |
| Healthy control | Other | Covid-19 antibody levels of healthy controls will be measured Receives: Other: COVID-19 antibody test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody levels
COVID-19 antibody titers of the patients will be measured in blood samples.
Measured: 1 month
Secondary outcomes (1)
Side effects
Participants will be questioned for common side effects
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe İrem Yasin, Bezmialem Vakif University
- Investigators
- MAHMUT GUMUS, PROF, Study chair, MEDENIYET UNIVERSITYAHMET BILICI, PROF, Study chair, Medipol UniversityHACI MEHMET TURK, PROF, Study chair, BEZMIALEM UNIVERSITYMESUT SEKER, PROF, Study director, BEZMIALEM UNIVERSITYAYSE IREM YASIN, MD, Principal investigator, BEZMIALEM UNIVERSITYBILGE SUMBUL, ASOC.PROF., Study chair, BEZMIALEM UNIVERSITYFAYSAL DANE, PROF, Study chair, Acibadem UniversityCAGLAYAN GEREDELI, ASOC.PROF., Study chair, OKMEYDANI RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771559
- Sponsor's protocol ID
- 132620
- Status last verified
- Aug 2021
- First submitted
- 17 Feb 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35081732
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect and Side Effect Profile of Covid-19 Vaccine in Cancer Patients
- ClinicalTrials.gov ID
- NCT04771559
- Acronym / sponsor ID
- 132620
- Keywords
- Cancer, Covid-19, Vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | Other | Other: COVID-19 antibody testCovid-19 antibody levels of patients will be measured |
| Healthy control | Other | Other: COVID-19 antibody testCovid-19 antibody levels of healthy controls will be measured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- No known cancer diagnosis or history
Key exclusion criteria (4 listed)
- Not volunteering to participate in the study
- < 18 years
- Not administered two doses of the COVID-19 vaccine
- Covid-19 infection history -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 antibody test5 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 | Other | Cancer patients, Healthy control |
Primary outcome
Antibody levels
Time frame: 1 month
COVID-19 antibody titers of the patients will be measured in blood samples.
1 secondary outcome
Side effects
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Derived from this study: PubMed 35081732Yasin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAHMUT GUMUS, PROF study chair
MEDENIYET UNIVERSITY
AHMET BILICI, PROF study chair
Medipol University
HACI MEHMET TURK, PROF study chair
BEZMIALEM UNIVERSITY
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 antibody test in people with Covid19 and Cancer, run by Bezmialem Vakif University at 5 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody levels (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.