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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018609
Receipt No. 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

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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
Email 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
Email nokita@ncc.go.jp

Sponsor
Institute National cancer center hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019020

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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