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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031608
Receipt No. R000036081
Scientific Title Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer
Date of disclosure of the study information 2018/03/12
Last modified on 2018/08/28

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Basic information
Public title Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer
Acronym Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer
Scientific Title Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer
Scientific Title:Acronym Medical team treatment decision of immune-checkpoint inhibitor in non-small cell 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 Early identification of beneficial patients in patients treated with immune checkpoint inhibitors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The correct rate of decision on 28 days after the start of administration
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Histologically or cytologically confirmed non-small cell lung cancer
2 At least one regimen or more of chemotherapy has been performed
3 18 years-old or over
4 Patients were judged appropriate by the attending physician as subjects of immune checkpoint inhibitors
5 Whether or not there is an evaluable lesion is not required
6 Patients who have adequate organ function
7 Patients provided written imformed consent
Key exclusion criteria 1 Patients who the physician judges unsuitable for this study
2 Patients who had pretreatment with immune checkpoint inhibitor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Hirashima
Organization Osaka Habikino medical center
Division name Department of thoracic oncology
Zip code
Address 3-7-1 habikino habikino-city OSAKA
TEL 0729572121
Email hirashimat@opho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Suzuki
Organization Osaka Habikino Medical Center
Division name Department of Thoracic oncology
Zip code
Address 3-7-1 habikino habikino-city OSAKA
TEL 0729572121
Homepage URL
Email suzukih@opho.jp

Sponsor
Institute Osaka Habikino Medical Center
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
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 大阪はびきの医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 12 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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 12 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2018 Year 03 Month 06 Day
Last modified on
2018 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036081

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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