UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016386 |
|---|---|
| Receipt number | R000019032 |
| Scientific Title | An observational cohort study on the prediction for lifestyle-related diseases and cancer using plasma amino acid profiles |
| Date of disclosure of the study information | 2015/01/31 |
| Last modified on | 2015/01/30 13:50:30 |
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Basic information
Public title
An observational cohort study on the prediction for lifestyle-related diseases and cancer using plasma amino acid profiles
Acronym
An observational cohort study on the prediction for lifestyle-related diseases and cancer using plasma amino acid profiles
Scientific Title
An observational cohort study on the prediction for lifestyle-related diseases and cancer using plasma amino acid profiles
Scientific Title:Acronym
An observational cohort study on the prediction for lifestyle-related diseases and cancer using plasma amino acid profiles
Region
| Japan |
Condition
Condition
Lifestyle-related diseases and cancer
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of the prediction for lifestyle-related diseases and cancer using plasma amino acid profiles
Basic objectives2
Others
Basic objectives -Others
The clinical utility of plasma free amino acids as biomarkers
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Development of lifestyle-related diseases and cancer, plasma amino acid concentrations
Key secondary outcomes
Variables regarding lifestyle-related diseases and cancer
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
The subjects undergoing human dry dock who agreed to the informed consent to participate in the study
Key exclusion criteria
1. Hepatitis C patient
2. HIV patient
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Ishizaka |
Organization
Mitsui Memorial Hospital
Division name
Center for Multiphasic Health Testing and Services
Zip code
Address
Kanda, Izumicho, Chiyoda-ku, Tokyo
TEL
03-3862-9111
yishizaka-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Ishizaka |
Organization
Mitsui Memorial Hospital
Division name
Center for Multiphasic Health Testing and Services
Zip code
Address
Kanda, Izumicho, Chiyoda-ku, Tokyo
TEL
03-3862-9111
Homepage URL
yishizaka-circ@umin.ac.jp
Sponsor or person
Institute
Ajinomoto Co., Inc.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
三井記念病院総合健診センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
An observational cohort study
Management information
Registered date
| 2015 | Year | 01 | Month | 30 | Day |
Last modified on
| 2015 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019032
