UMIN-CTR Clinical Trial

Basic information
Public title	Single-institutional observational surveillance of nivolumab for previously treated with non-small cell lung cancer
Acronym	observational study of nivolumab
Scientific Title	Single-institutional observational surveillance of nivolumab for previously treated with non-small cell lung cancer
Scientific Title:Acronym	observational study of nivolumab
Region	Japan

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

Objectives
Narrative objectives1	To investigate the predictive factor response with clinical characteristics
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	response rate
Key secondary outcomes	progression-free survival; overall survival; safety; predictive factor of prognosis and safety

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients treated with nivolumab for previously treated with NSCLC from 2016
Key exclusion criteria	inadequate patients for nivolumab treatment
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Okuma
Organization	Tokyo Metropolitan Komagome Hospital
Division name	Department of Thoracic Oncology
Zip code	113-8677
Address	3-18-22, Honkomagome, Bunkyo, Tokyo, JAPAN
TEL	03-3823-2101
Email	y-okuma@cick.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Okuma
Organization	Tokyo Metropolitan Komagome Hospital
Division name	Department of Thoracic Oncology
Zip code	113-8677
Address	3-18-22, Honkomagome, Bunkyo, Tokyo, JAPAN
TEL	03-3823-2101
Homepage URL
Email	y-okuma@cick.jp

Sponsor
Institute	Tokyo Metropolitan Komagome Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Komagome Hospital
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	Ethics committee of Tokyo Metropolitan Komagome Hospital
Address	3-28-22, Honkomagome, Bunkyo, Tokyo
Tel	03-3823-2101
Email	rinri@cick.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	2016 Year 04 Month 01 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pubmed/30655989
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/30655989
Number of participants that the trial has enrolled	67
Results	The patients who were treated with nivolumab as the standard of care were enrolled.
Results date posted	2019 Year 03 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The patients who were treated with nivolumab as the standard of care were enrolled.
Participant flow	The patients who were treated with nivolumab as the standard of care were enrolled.
Adverse events	we have published in the articles
Outcome measures	we have published in the articles
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 03 Month 12 Day
Date of IRB	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Case control study. We will assess clinical demographic, diagnosis, histological subtypes, treatment of nivolumab, clinical outcome (response, time-to-event), or laboratory data.

Management information
Registered date	2016 Year 03 Month 30 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=R000024740

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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