UMIN-CTR Clinical Trial

Basic information
Public title	Immune checkpoint inhibitor-associated pneumonitis in patients with thoracic malignancy: Multicenter prospective observational study
Acronym	Immune checkpoint inhibitor-associated pneumonitis: Multicenter prospective observational study
Scientific Title	Immune checkpoint inhibitor-associated pneumonitis in patients with thoracic malignancy: Multicenter prospective observational study
Scientific Title:Acronym	Immune checkpoint inhibitor-associated pneumonitis: Multicenter prospective observational study
Region	Japan

Condition
Condition	thoracic malignancy
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify incidence and risk factors of immune checkpoint inhibitor-associated pneumonitis in patients with thoracic malignancy in clinical practice.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of immune checkpoint inhibitor-associated pneumonitis
Key secondary outcomes	Risk factors for the development of immune checkpoint inhibitor-associated pneumonitis

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 with thoracic malignancy who will receive nivolumab or pembrolizumab or atezolizumab
Key exclusion criteria	nothing
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
Address	1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka
TEL	053-435-2111
Email	Suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Takafumi Middle name Last name Koyauchi
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
Address	1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka
TEL	053-435-2111
Homepage URL
Email	t.koya@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
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	the Institutional Review Board of Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka
Tel	053-435-2111
Email	hama-med@esct.bvits.com

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	2020 Year 04 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	Open public recruiting
Date of protocol fixation	2019 Year 05 Month 15 Day
Date of IRB	2019 Year 05 Month 15 Day
Anticipated trial start date	2019 Year 05 Month 15 Day
Last follow-up date	2024 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A prospective observational study investigating the incidence of pneumonitis and risk factors in patients using nivolumab, pembrolizumab, or atezolizumab.

Management information
Registered date	2020 Year 03 Month 10 Day
Last modified on	2020 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045349