UMIN-CTR Clinical Trial

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	No longer recruiting
Date of protocol fixation	2017 Year 01 Month 25 Day
Date of IRB	2017 Year 01 Month 24 Day
Anticipated trial start date	2017 Year 02 Month 14 Day
Last follow-up date	2023 Year 03 Month 31 Day
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	2022 Year 09 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030359