UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008950 |
|---|---|
| Receipt number | R000010101 |
| Scientific Title | Comprehensive analysis of somatic mutations in small cell lung cancer exploring new therapeutic targets |
| Date of disclosure of the study information | 2012/09/20 |
| Last modified on | 2022/09/28 10:07:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sumemura@east.ncc.go.jp
Sponsor or person
Institute
Division of Thoracic Oncology, National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010101
