UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective analysis for the predictive factors for severe adverse event in the patients of advanced non-small cell lung cancer who treated with anti-PD-1 antibody
Acronym	Adverse events of anti-PD-1 antibody and predictive factors in patients with lung cancer
Scientific Title	A retrospective analysis for the predictive factors for severe adverse event in the patients of advanced non-small cell lung cancer who treated with anti-PD-1 antibody
Scientific Title:Acronym	Adverse events of anti-PD-1 antibody and predictive factors in patients with lung cancer
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify predictive factors for severe adverse events of anti-PD-1 antibody in patients with advanced non-small cell lung cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of severe adverse events
Key secondary outcomes	response rate, progression-free survival

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 in whom NSCLC had been histologically diagnosed from January 2016 to February 2018 at Kansai Medical University Medical Center and treated with anti-PD-1 antibody.
Key exclusion criteria	Patients refused to participate of this study, judged as inappropriate by principal investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Tamaki
Organization	Kansai Medical University Medical Center
Division name	First Department of Internal Medicine
Zip code	570-8507
Address	Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL	06-6992-1001
Email	tamakit@takii.kmu.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Tamaki
Organization	Kansai Medical University Medical Center
Division name	First Department of Internal Medicine
Zip code	570-8507
Address	Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL	06-6992-1001
Homepage URL
Email	tamakit@takii.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	None
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 Ethics Review Board of Kansai Medical University Medical Center
Address	Fumizono-cho 10-15, Moriguchi-city, Osaka.
Tel	06-6992-1001
Email	kouhou@takii.kmu.ac.jp

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	2018 Year 08 Month 20 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	60
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	No longer recruiting
Date of protocol fixation	2018 Year 05 Month 01 Day
Date of IRB	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 08 Month 21 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 05 Month 31 Day
Date analysis concluded	2023 Year 11 Month 30 Day

Other
Other related information	Retrospective study All the patients met the criteria for selection, in whom NSCLC had been histologically diagnosed from January 2016 to February 2018 at Kansai Medical University Medical Center and treated with anti-PD-1 antibody.

Management information
Registered date	2018 Year 08 Month 20 Day
Last modified on	2022 Year 08 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038580