UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005490 |
|---|---|
| Receipt number | R000006153 |
| Scientific Title | Development of molecular biomarker for colorectal cancer |
| Date of disclosure of the study information | 2011/04/30 |
| Last modified on | 2021/04/29 11:51:42 |
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Basic information
Public title
Development of molecular biomarker for colorectal cancer
Acronym
Development of molecular biomarker for colorectal cancer
Scientific Title
Development of molecular biomarker for colorectal cancer
Scientific Title:Acronym
Development of molecular biomarker for colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to develop biomarkers that can predict prognosis and chemo sensitivity in colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
predictability of prognosis.
predictability of chemo sensitivity.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
adult patients with stage II to IV colorectal cancer who approved informed consent.
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Takahashi |
Organization
Institute of Development, Aging and Cancer, Tohoku Univ.
Division name
Department of Clinical Oncology
Zip code
980-8575
Address
4-1, Seiryo-machi, Aobaku, Miyagi, Japan
TEL
022-717-8543
shin.takahashi.e7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Takahashi |
Organization
Institute of Development, Aging and Cancer, Tohoku Univ.
Division name
Department of Clinical Oncology
Zip code
980-8575
Address
4-1, Seiryo-machi, Aobaku, Miyagi, Japan
TEL
022-717-8547
Homepage URL
shin.takahashi.e7@tohoku.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology, Institute of Development, Aging and Cancer, Tohoku Univ.
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the School of Medicine, Tohoku University School of Medicine
Address
1-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan
Tel
022-717-8007
med-kenkyo@bureau.tohoku.ac.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 30 | 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
| 2009 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2011 | Year | 04 | Month | 22 | Day |
Last modified on
| 2021 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006153
