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Name
UMIN ID

Recruitment status
Unique ID issued by UMIN UMIN000022427
Receipt No. R000025734
Scientific Title Evaluating quality of life in patients with non-small cell lung cancer treated with Nivolumab
Date of disclosure of the study information 2016/10/30
Last modified on 2016/05/24

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Basic information
Public title Evaluating quality of life in patients with non-small cell lung cancer treated with Nivolumab
Acronym Evaluating quality of life in patients with non-small cell lung cancer treated with Nivolumab
Scientific Title Evaluating quality of life in patients with non-small cell lung cancer treated with Nivolumab
Scientific Title:Acronym 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

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 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
1st name
Middle name
Last name Ogawara Daiki
Organization Sasebo City General Hospital
Division name Respiratory medicine
Zip code
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
1st name
Middle name
Last name Ogawara Daiki
Organization Sasebo City General Hospital
Division name Respiratory medicine
Zip code
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

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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 10 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
Date of protocol fixation
2016 Year 04 Month 18 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025734

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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