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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026425
Receipt No. R000030359
Scientific Title A prospective observational biomarker study for lung cancer immunotherapy
Date of disclosure of the study information 2017/03/06
Last modified on 2017/03/06

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Basic information
Public title A prospective observational biomarker study for lung cancer immunotherapy
Acronym Immuno-Oncology Biomarker Study (LC-SCRUM-IBIS)
Scientific Title A prospective observational biomarker study for lung cancer immunotherapy
Scientific Title:Acronym Immuno-Oncology Biomarker Study (LC-SCRUM-IBIS)
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This Study is intended to analyze the expression of PD-L1 and changes in various somatic genes associated with lung cancer, and by evaluating the relationship between the results of such analysis and clinicopathologic factors, therapeutic effects, and prognosis, and to explore new biomarkers for immune therapies for treatment of lung cancer.
Basic objectives2 Others
Basic objectives -Others The incidence of expression of PD-L1 in lung cancer
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of expression of PD-L1 in lung cancer
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) Patients with a pathologic diagnosis of lung cancer (either biopsy or cytological diagnosis);
2) Patients who are or will be enrolled in one of the 3 observational studies of LC-SCRUM-Japan, and at the same time, in whom fresh frozen sample + 10 slides of unstained preparation for genetic analysis and blood samples can be collected; and
3) Patients who consent in writing to take part in the Study.
Key exclusion criteria Not applicable
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Goto
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Email kgoto@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyotaka Yoh
Organization National Cancer Center Hospital East
Division name Department of Thoracic Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email kyoh@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
CHUGAI PHARMACEUTICAL CO., LTD.
AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 03 Month 06 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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The incidence of expression of PD-L1 in lung cancer

Management information
Registered date
2017 Year 03 Month 06 Day
Last modified on
2017 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030359

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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