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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021548
Receipt No. R000024846
Scientific Title Impact of immune check point inhibitors on airway function test and airway inflammations
Date of disclosure of the study information 2016/03/30
Last modified on 2019/03/22

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Basic information
Public title Impact of immune check point inhibitors on airway function test and airway inflammations
Acronym Impact of immune check point inhibitors on airway function test and airway inflammations
Scientific Title Impact of immune check point inhibitors on airway function test and airway inflammations
Scientific Title:Acronym Impact of immune check point inhibitors on airway function test and airway inflammations
Region
Japan

Condition
Condition cancer patients treated with immune checkpoint inhibitors
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigate the impact of immune checkpoint inhibitors on airway function test and airway inflammations
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pulmonary function, Exhaled NO, inflammatory markers in 8 weeks after treatments
Key secondary outcomes Exacerbation of airway inflammations

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 Cancer patients who are treated with immune checkpoint inhibitors
Key exclusion criteria Patients not obtained written informed consents
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1 Hanadayama Higashi-ku, Hamamatsu, Shizuoka 431-3192 Japan
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuzo Suzuki
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1 Hanadayama Higashi-ku, Hamamatsu, Shizuoka 431-3192 Japan
TEL 053-435-2263
Homepage URL
Email yuzosuzu@hama-med.ac.jp

Sponsor
Institute Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Seireimikatahara General Hospital
Seirei Hamamatsu Hospital
Tenryu Hospital
Hamamatsu Medical Center
Enshu Hospital
Hamamatsu Rosai Hospital
Iwata City Hospital
Fujieda City Hospital
Shizuoka Ciy Shizuoka Hospital
Hamamatsu Red-cross Hospital
Shizuoka Red-cross Hospital
Shizuoka Saiseikai Hospital
Shizuoka City Shimizu Hospital
Shizuoka General Hospital

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 浜松医科大学附属病院(静岡県)
聖隷三方原病院(静岡県)
聖隷浜松病院(静岡県)
国立病院機構天竜病院(静岡県)
県西部浜松医療センター(静岡県)
遠州病院(静岡県)
浜松労災病院(静岡県)
磐田市立総合病院(静岡県)
藤枝市立総合病院(静岡県)
静岡市立静岡病院(静岡県)
浜松赤十字病院(静岡県)
静岡赤十字病院(静岡県)
静岡済生会総合病院(静岡県)
静岡市立清水病院(静岡県)
静岡県立総合病院(静岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 30 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 Completed
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
2016 Year 03 Month 24 Day
Anticipated trial start date
2016 Year 03 Month 29 Day
Last follow-up date
2019 Year 01 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cohort study
Enrollment criteria: Patients who meet enrollment criteria since March 2016
Investigate the impact of immune check measurements: airway function and airway inflammations

Management information
Registered date
2016 Year 03 Month 19 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024846

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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