UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049430 |
|---|---|
| Receipt number | R000056281 |
| Scientific Title | Prospective observational study on the impact of vaccination against COVID-19 among National Cancer Center staff. |
| Date of disclosure of the study information | 2022/11/04 |
| Last modified on | 2024/05/06 11:10:33 |
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Basic information
Public title
Prospective observational study on the impact of vaccination against COVID-19 among National Cancer Center staff.
Acronym
Prospective observational study on the impact of vaccination against COVID-19 among National Cancer Center staff.
Scientific Title
Prospective observational study on the impact of vaccination against COVID-19 among National Cancer Center staff.
Scientific Title:Acronym
Prospective observational study on the impact of vaccination against COVID-19 among National Cancer Center staff.
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
SARS-CoV-2 antibodies will be measured by blood specimen from employees at National Cancer Center before/after they have been vaccinated against COVID-19
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SARS-CoV-2 antibody positivity after 2 doses of vaccine
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) an employee of the National Cancer Center
2) Subjects who have given written consent for this study
3) The subject is scheduled to receive the COVID19 or is within 12 months of receiving the second (or last) dose of the vaccine.
Key exclusion criteria
Subjects who are determined not to be appropriate subjects for this study by the Principal Investigator or the Research Office
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Katsuya |
Organization
National cancer center hospital
Division name
Department of experimental development
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
ykatsuya@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Katsuya |
Organization
National Cancer Center Hospital
Division name
Department of experimental development
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
ykatsuya@ncc.go.jp
Sponsor or person
Institute
National cancer center
Institute
Department
Personal name
Funding Source
Organization
National cancer center hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer center
Address
5-1-1, Tsukiji, Chu-ku, Tokyo
Tel
0335422511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-077
Org. issuing International ID_1
National cancer center hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10147-024-02470-x
Number of participants that the trial has enrolled
209
Results
Seroconversion rates were measured before and after vaccination. 96.1% of cancer patients had adequate antibody levels 1-3 months after the second dose, compared to 100% of healthy controls. After 4-6 months, 93.1% of cancer patients still showed adequate response. Factors like age, gender, and treatment type affected vaccine efficacy in cancer patients. COVID-19 vaccines are less effective in cancer patients, particularly under certain treatments.
Results date posted
| 2024 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 21 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 02 | Month | 21 | Day |
Other
Other related information
Katsuya Y, Yoshida T, Takashima A, Yonemori K, Ohba A, Yazaki S, Yagishita S, Nakahama H, Kobayashi O, Yanagida M, Irino Y, Hamada A, Yamamoto N. Immunogenicity after vaccination of COVID-19 vaccines in patients with cancer: a prospective, single center, observational study. Int J Clin Oncol. 2024 Apr;29(4):386-397. doi: 10.1007/s10147-024-02470-x. Epub 2024 Feb 21. PMID: 38381163; PMCID: PMC10963526.
Management information
Registered date
| 2022 | Year | 11 | Month | 04 | Day |
Last modified on
| 2024 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056281
