UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029565 |
|---|---|
| Receipt number | R000033780 |
| Scientific Title | Immune-related gene signiture profiling in CRC, non-CRC, and lung cancer. |
| Date of disclosure of the study information | 2017/10/15 |
| Last modified on | 2022/04/26 16:28:51 |
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Basic information
Public title
Immune-related gene signiture profiling in CRC, non-CRC, and lung cancer.
Acronym
IOP
Scientific Title
Immune-related gene signiture profiling in CRC, non-CRC, and lung cancer.
Scientific Title:Acronym
IOP
Region
| Japan |
Condition
Condition
CRC, nonCRC, lung cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Imuune-related gene signiture profiling
Basic objectives2
Others
Basic objectives -Others
the relationship between Imuune-related gene signiture profiling and clinicopathological features, effiicacy of anti-PD-1/PD-L1 and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Imuune-related gene signiture profiling
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) cases who were registered in SCRUM-Japan and agreed with secondary use of data and materials
2)cases with enough remaing specimen
Key exclusion criteria
cases who are considered as excluded by the physician
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East, Japan
Division name
Department of GI oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shiChiba-ken, 277-8577 Japan
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Kawazoe |
Organization
National Cancer Center Hospital East, Japan
Division name
Department of GI oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shiChiba-ken, 277-8577 Japan
TEL
04-7133-1111
Homepage URL
akawazoe@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center, Japan
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Kyowa Hakko Kirin Company, Limited
MSD
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
National Cancer Center Institutional Review Board
Address
5-1-1, tsukiji, tyuo-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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 15 | 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
651
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
| 2017 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 10 | Month | 15 | Day |
Last modified on
| 2022 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033780
