UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluating quality of life in patients with non-small cell lung cancer treated with Nivolumab
Title of the study (Brief title)	Evaluating quality of life in patients with non-small cell lung cancer treated with 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 examine the QOL changes by Nivolumab therapy in patients with non-small cell lung cancer
Basic objectives2	Others
Basic objectives -Others	prospective observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	QOL evaluation (FACT-L)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Stage IIIB or IV non-small cell lung cancer, Histologically or cytologically confirmed Non-small cell lung cancer patients with treatment history ECOG performance status must be 0-2 Acquisition of written informed consent
Key exclusion criteria	Patients without notification of their cancer disease Patients with potential disease affecting QOL survey and handgrip test. Those judged to be not suitable by the attending physician
Target sample size	50

Research contact person
Name of lead principal investigator	Ogawara Daiki
Organization	Sasebo City General Hospital
Division name	Respiratory medicine
Address	9-3 Hirase-machi, Sasebo city, Nagasaki, Japan
TEL	0956-24-1515
Email	dogawara@hospital.sasebo.nagasaki.jp

Public contact
Name of contact person	Ogawara Daiki
Organization	Sasebo City General Hospital
Division name	Respiratory medicine
Address	9-3 Hirase-machi, Sasebo city, Nagasaki, Japan
TEL	0956-24-1515
Homepage URL
Email	dogawara@hospital.sasebo.nagasaki.jp

Sponsor
Institute	Sasebo City General Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 10 Month 30 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 04 Month 18 Day
Anticipated trial start date	2016 Year 04 Month 19 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	now entry

Management information
Registered date	2016 Year 05 Month 24 Day
Last modified on	2016 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025734