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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034646
Receipt No. 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

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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
Email 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
Email chikamori@yamaguchi-hosp.jp

Sponsor
Institute NHO Yamaguchi-Ube Medical Center
Clinical Research division
Institute
Department

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
Email

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
URL(English) https://upload.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


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