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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016386
Receipt No. 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

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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
Email 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
Email yishizaka-circ@umin.ac.jp

Sponsor
Institute Ajinomoto Co., Inc.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019032

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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