UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049403 |
|---|---|
| Receipt number | R000056250 |
| Scientific Title | Prospective observational study on the impact of vaccination against COVID19 in patients with cancer |
| Date of disclosure of the study information | 2022/11/02 |
| Last modified on | 2024/05/06 11:22:44 |
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Basic information
Public title
Prospective observational study on the impact of vaccination against COVID19 in patients with cancer
Acronym
Prospective observational study on the impact of vaccination against COVID19 in patients with cancer
Scientific Title
Prospective observational study on the impact of vaccination against COVID19 in patients with cancer
Scientific Title:Acronym
Prospective observational study on the impact of vaccination against COVID19 in patients with cancer
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Blood samples will be collected from patients with cancer at the National Cancer Center Hospital after vaccination for COVID-19 to determine the prevalence of SARS-CoV-2 antibodies. We will examine the influence of the background of the carcinoma patients (cancer type, stage, treatment, etc.) on the efficacy of COVID-19 vaccine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age 16 years or older at the time of consent
2) Patients with cancer at the National Cancer Center Hospital (regardless of cancer type or stage)
3) Have blood samples taken at this hospital at least once every three months.
4) Adults whose written consent for this study has been obtained by the patient, or minors whose written consent for this study has been obtained by the patient
5) Scheduled to receive COVID-19 vaccine or within approximately 6 months of the second (or last) dose of the vaccine
Key exclusion criteria
Subjects who are determined by the principal investigator or physician in charge to be inappropriate as subjects for this study
Target sample size
1000
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
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
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
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
ykatsuya@ncc.go.jp
Sponsor or person
Institute
National cancer center hospital
Institute
Department
Personal name
Funding Source
Organization
National cancer center hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer center
Address
5-1-1, Tsukiji, Chuo-ku
Tel
03-3542-2511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-582
Org. issuing International ID_1
Natinal cancer center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10147-024-02470-x
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
589
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
Baseline Characteristics
In total, 590 patients and 183 healthy hospital staff were analyzed.
Participant flow
We enrolled participants from two groups. Patients and hospital staff. Patients aged over 16 years and with cancer regardless of stage, histology, and treatment, that were taking blood tests at least every 3 months were eligible. Individuals working at National Cancer Center Hospital taking or planning to take COVID-19 vaccines were eligible, regardless of complications. Considering the effect of complications such as hypertension, diabetes, cancer, and autoimmune diseases on immunogenicity, hospital staff without complications were referred to as healthy controls.
Adverse events
No adverse events of note
Outcome measures
SARS-CoV-2 spike protein-specific IgG concentrations were evaluated before the first vaccination, and 1-3 and 4-6 months after the second vaccination. The primary endpoint was the seroconversion rate measured 1-3 months after the second vaccine.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 12 | 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 | 02 | 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=R000056250
