UMIN-CTR Clinical Trial

Basic information
Public title	Lung Cancer Genomic Screening Project for Individualized Medicine in Japan
Acronym	LC-SCRUM-Japan
Scientific Title	Lung Cancer Genomic Screening Project for Individualized Medicine in Japan
Scientific Title:Acronym	LC-SCRUM-Japan
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To clarify the lung cancer with RET Fusion-positive, newly reported as a gene responsible for the lung cancer, and characterize its clinicopathological and molecular feature
Basic objectives2	Others
Basic objectives -Others	To analyze a variety of genetic alterations, including RET fusion, by a multiplex gene testing.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify the clinicopathological and molecular feature in RET fusion-positive 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. Histologically or cytologically diagnosed NSCLC 2. Clinical stage II, III or IV 3. Eastern Cooperative Oncology Group performance status (PS) of 0 or 1 4. Adequate function of main organ that meets the following criteria -1 Neutrophil count>=1500/mm3 -2 Hemoglobin>=8.0g/dL -3 Platelet count>=7.5*104/mm3 -4 AST,ALT<=upper limit of normal *2.5 5 Serum bilirubin <=upper limit of normal *1.5 mg/dL 5. Other serious medical complications (interstitial pneumonitis, uncontrolled diabetes mellitus, heart failure, active infectious disease etc.) 6. Life expectancy more than 3 months 7. Materials available for genome analysis 8. Declaring enrollement of clinical trial through genome analysis 9. Written informed consent
Key exclusion criteria	none
Target sample size	6500

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Goto
Organization	National Cancer Center Hospital East
Division name	Division of Thoracic Oncology
Zip code	277-8577
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 Koichi Middle name Last name Goto
Organization	National Cancer Center Hospital East
Division name	Division of Thoracic Oncology
Zip code	277-8577
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	04-7133-1111
Homepage URL
Email	kgoto@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Cancer Genome Screening Project for Individualized Medicine in Japan(SCRUM-Japan)
Name of secondary funder(s)	Japan Agency for Medical Research and Deveropment

IRB Contact (For public release)
Organization	National Cancer Center Hospital East
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
Tel	04-7133-1111
Email	irst@ml.res.ncc.go.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	2013 Year 03 Month 13 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	Completed
Date of protocol fixation	2012 Year 11 Month 26 Day
Date of IRB	2013 Year 01 Month 29 Day
Anticipated trial start date	2013 Year 02 Month 13 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry	2019 Year 08 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a prospective observational study.

Management information
Registered date	2013 Year 03 Month 13 Day
Last modified on	2020 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011979