UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010234 |
|---|---|
| Receipt number | R000011979 |
| Scientific Title | Lung Cancer Genomic Screening Project for Individualized Medicine in Japan |
| Date of disclosure of the study information | 2013/03/13 |
| Last modified on | 2020/10/01 13:23:05 |
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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
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
kgoto@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011979
