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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021600
Receipt No. R000024910
Scientific Title A prospective observational study of immune-checkpoint inhibitor (Nivolumab) treatment in patients with non-small cell lung cancer
Date of disclosure of the study information 2016/03/24
Last modified on 2019/09/26

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Basic information
Public title A prospective observational study of immune-checkpoint inhibitor (Nivolumab) treatment in patients with non-small cell lung cancer
Acronym A prospective observational study of Nivolumab treatment
Scientific Title A prospective observational study of immune-checkpoint inhibitor (Nivolumab) treatment in patients with non-small cell lung cancer
Scientific Title:Acronym A prospective observational study of Nivolumab treatment
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Monitoring a progress of Nivolumab treatment for non-small cell lung cancer patients to evaluate the efficacy and adverse effects
Basic objectives2 Others
Basic objectives -Others Search of biomarkers to predict the efficacy or adverse effects by Nivolumab treatment
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Monitoring a progress of Nivolumab treatment for non-small cell lung cancer patients
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Diagnosed with non-small cell lung cancer
2)Scheduled for administration of Nivolumab
3)With written informed consent
Key exclusion criteria None
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Jiichiro
Middle name
Last name Sasaki
Organization Kitasato University School of Medicine
Division name Research and Development Center for New Medical Frontiers
Zip code 252-0374
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL 042-778-8111
Email saji@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Tomoya
Middle name
Last name Fukui
Organization Kitasato University School of Medicine
Division name Department of Respiratory Medicine
Zip code 252-0374
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL 042-778-8111
Homepage URL
Email tofukui@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Kitasato 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 Kitasato University Medical Ethics Organization
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel 042-778-7756
Email rinri@med.kitasato-u.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
2016 Year 03 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 52
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 Main results already published
Date of protocol fixation
2016 Year 03 Month 03 Day
Date of IRB
2016 Year 03 Month 03 Day
Anticipated trial start date
2016 Year 03 Month 03 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 50 non-small cell lung cancer patients who are treated with Nivolumab in Kitasato University Hospital between March 2016 and February 2018

Management information
Registered date
2016 Year 03 Month 24 Day
Last modified on
2019 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024910

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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