UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044213 |
|---|---|
| Receipt number | R000050488 |
| Scientific Title | A prospective observational study to investigate the safety of SARS-Cov-2 vaccine for patients with advanced lung cancer who are treated with immune checkpoint inhibitor. |
| Date of disclosure of the study information | 2021/05/14 |
| Last modified on | 2021/05/14 23:13:45 |
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Basic information
Public title
A prospective observational study to investigate the safety of SARS-Cov-2 vaccine for patients with advanced lung cancer who are treated with immune checkpoint inhibitor.
Acronym
Association between immune related adverse events and novel coronavirus vaccine for advanced lung cancer patients
Scientific Title
A prospective observational study to investigate the safety of SARS-Cov-2 vaccine for patients with advanced lung cancer who are treated with immune checkpoint inhibitor.
Scientific Title:Acronym
Association between immune related adverse events and novel coronavirus vaccine for advanced lung cancer patients
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the safety of SARS-Cov-2 vaccine for lung cancer patients who are treated with immune checkpoint inhibitor.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of adverse events related with immune checkpoint inhibitor in 3 months after the vaccination.
Key secondary outcomes
The frequency of adverse events related with immune checkpoint inhibitor in 6 months after the vaccination.
The frequency of adverse reactions after the vaccination
The rate of vaccination during the observation period of this study.
The rate of infection for COVID-19 after the vaccination
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have NSCLC with histologically or cytologically confirmed
Patients who have locally advanced, metastatic or recurrent lung cancer
Patients who are treated/will be treated with immune checkpoint inhibitor
Patients who have willing to receive the SARS-Cov-2 vaccine, but have not yet been vaccinated
Patients are enrolled if they are over 20 years old
Patients are enrolled if they can write written consent form after they listen the explanation of this study and consent the study.
Key exclusion criteria
Patients that doctor in charge consider them inappropriate as a subject
Patients who had already infected with COVID-19
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Kawai |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Respiratory Medicine
Zip code
113-0021
Address
3-18 Honkomagome, Bunkyo-ku, Tokyo,Japan
TEL
03-3823-2101
river.happiness@cick.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Kawai |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Respiratory Medicine
Zip code
113-0021
Address
3-18 Honkomagome, Bunkyo-ku, Tokyo,Japan
TEL
03-3823-2101
Homepage URL
river.happiness@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address
3-18 Honkomagome, Bunkyo-ku, Tokyo,Japan
Tel
03-3823-2101
river.happiness@cick.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The frequency of adverse events related with immune checkpoint inhibitor in 3 months after the vaccination.
The frequency of adverse events related with immune checkpoint inhibitor in 6 months after the vaccination.
The frequency of adverse reactions after the vaccination
The rate of vaccination during the observation period of this study.
The rate of infection for COVID-19 after the vaccination
Management information
Registered date
| 2021 | Year | 05 | Month | 14 | Day |
Last modified on
| 2021 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050488
