UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000024846