UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034646 |
|---|---|
| Receipt number | R000039484 |
| Scientific Title | Prospective multicenter observational study; Safety of influenza vaccination for the lung cancer patients treated with immune-checkpoint inhibitor |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2018/10/25 18:06:17 |
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Basic information
Public title
Prospective multicenter observational study; Safety of influenza vaccination for the lung cancer patients treated with immune-checkpoint inhibitor
Acronym
Safety of influenza vaccination for the lung cancer patients treated with immune-checkpoint inhibitor
Scientific Title
Prospective multicenter observational study; Safety of influenza vaccination for the lung cancer patients treated with immune-checkpoint inhibitor
Scientific Title:Acronym
Safety of influenza vaccination for the lung cancer patients treated with immune-checkpoint inhibitor
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety evaluation of influenza vaccination for the lung cancer patients treated with immune-checkpoint inhibitor
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
incidence rate of severe immune-related adverse event after influenza vaccination among the lung cancer patients treated with immune-checkpoint inhibitor
Key secondary outcomes
incidence rate of severe immune-related adverse event without influenza vaccination among the lung cancer patients treated with immune-checkpoint inhibitor and incidence rate of influenza infection
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
Written informed consent
Advanced or relapsed non-small cell lung cancer
Administration of immune-checkpoint inhibitor
Key exclusion criteria
History of severe immune-related adverse event
Immune-checkpoint inhibitor has been already stopped.
Administration of steroid and/or immunnosuppresive therapy
Influenza infection within 2 month
Anti-influenza therapy within 2 month
Comorbidities of active infectious disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Chikamori |
Organization
NHO Yamaguchi-Ube Medical Center
Division name
Medical Oncology
Zip code
Address
Higashi-kiwa 685, Ube Yamaguchi
TEL
0836-58-2300
chikamori@yamaguchi-hosp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Chikamori |
Organization
NHO Yamaguchi-Ube Medical Center
Division name
Medical Oncology
Zip code
Address
Higashi-kiwa 685, Ube Yamaguchi
TEL
0836-58-2300
Homepage URL
chikamori@yamaguchi-hosp.jp
Sponsor or person
Institute
NHO Yamaguchi-Ube Medical Center
Clinical Research division
Institute
Department
Personal name
Funding Source
Organization
NHO Yamaguchi-Ube Medical Center
Clinical Research division
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Okayama Lung Cancer Study Group (OLCSG)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observation items
patient characteristics, name of immune-checkpoint inhibitor, date of influenza vaccination, date of adverse event, influenza infection, survival
Management information
Registered date
| 2018 | Year | 10 | Month | 25 | Day |
Last modified on
| 2018 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039484
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
