UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018609 |
|---|---|
| Receipt number | R000019020 |
| Scientific Title | Metabolomic analysis of colorectal cancer patients. |
| Date of disclosure of the study information | 2015/08/10 |
| Last modified on | 2020/02/12 08:35:52 |
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Basic information
Public title
Metabolomic analysis of colorectal cancer patients.
Acronym
Metabolomic analysis of colorectal cacer patients.
Scientific Title
Metabolomic analysis of colorectal cancer patients.
Scientific Title:Acronym
Metabolomic analysis of colorectal cacer patients.
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the utility of early colorectal cancer diagnosis using metabolomics analysis
Basic objectives2
Others
Basic objectives -Others
To examine the utility of predictive formula
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of predictive formula
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Colorectal cancer patients.
Patients who agreed to participate in the Biobank.
Key exclusion criteria
None
Target sample size
1350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Okamoto Koji |
Organization
National Cancer Center
Division name
Research Institute
Zip code
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3542-2511
kojokamo@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Okita Natsuko |
Organization
National cancer center hospital
Division name
Gastrointestinal medical oncology division
Zip code
Address
5-1-1 Tsukiji Chuo-ku Tokyo
TEL
03-3542-2511
Homepage URL
nokita@ncc.go.jp
Sponsor or person
Institute
National cancer center hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5370027/
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
GC/MSMS
Management information
Registered date
| 2015 | Year | 08 | Month | 09 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019020
