UMIN-CTR Clinical Trial

Basic information
Public title	Comprehensive analysis of somatic mutations in small cell lung cancer exploring new therapeutic targets
Acronym	Comprehensive analysis of somatic mutations in small cell lung cancer
Scientific Title	Comprehensive analysis of somatic mutations in small cell lung cancer exploring new therapeutic targets
Scientific Title:Acronym	Comprehensive analysis of somatic mutations in small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	To explore driver mutations involved in tumorigenesis and mutations associated with malignant characters, such as metastasis and invasion, in small cell lung cancer.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comprehensive somatic mutation analysis by whole exon next-generation sequencing Gene amplification analysis
Key secondary outcomes	Analysis of candidate somatic mutations in biopsy specimens Investigation of biological functions of candidate gene abnormalities using culture cell-system

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	Patients who were performed thoracic surgery or biopsy at National Cancer Center Hospital East Histologically confirmed small cell lung cancer With sufficient amount of tumor tissues for the analyses
Key exclusion criteria	None
Target sample size	580

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 277-8577
TEL	04-7133-1111
Email	kgoto@east.ncc.go.jp

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

Sponsor
Institute	Division of Thoracic Oncology, National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Higashi Hiroshima Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of the National Cancer Center, Japan
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel	03-3542-2511
Email	NCC_IRBoffice@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	国立がん研究センター東病院（千葉県）

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 20 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	2012 Year 02 Month 20 Day
Date of IRB	2012 Year 03 Month 05 Day
Anticipated trial start date	2012 Year 03 Month 05 Day
Last follow-up date	2025 Year 03 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2012 Year 09 Month 20 Day
Last modified on	2022 Year 09 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010101