UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051647 |
|---|---|
| Receipt number | R000057491 |
| Scientific Title | Cohort study to search for biomarkers that predict disease onset using human data, whole genome analysis, and gene expression profiling over 8 years of follow-up |
| Date of disclosure of the study information | 2023/07/19 |
| Last modified on | 2023/07/19 16:18:16 |
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Basic information
Public title
Whole genome analysis and gene expression profiling using peripheral blood cells to establish a new method for evaluation of medical diseases.
Acronym
Research for biomarkers to predict the onset of disease
Scientific Title
Cohort study to search for biomarkers that predict disease onset using human data, whole genome analysis, and gene expression profiling over 8 years of follow-up
Scientific Title:Acronym
Cohort study for biomarkers to predict disease onset
Region
| Japan |
Condition
Condition
Type 2 diabetes, hypertension, dyslipidemia, obesity, etc.
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objectives of this study are 1) to comprehensively compare and analyze gene expression in peripheral blood cells of individuals at high and low risk of developing lifestyle-related diseases (especially type 2 diabetes), including aging-related genes, and to establish a new pathological diagnosis method for lifestyle-related diseases based on the results of this analysis. We will also analyze the relationship between gene expression in peripheral blood, gene sequence characteristics, and other clinical tests and information to establish a new method of analyzing and diagnosing internal medicine diseases based on blood analysis.
Basic objectives2
Others
Basic objectives -Others
Whole genome analysis and comprehensive gene expression analysis of peripheral blood of patients with internal medicine diseases, in addition to lifestyle-related diseases, are expected to provide knowledge that will lead to the development of methods for diagnosis and prediction of therapeutic effects.
This could lead to the development of new diagnostic methods using blood for internal medicine diseases including lifestyle-related diseases.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Body composition, body weight, BMI, and blood pressure.
HbA1c, laboratory evaluations, including hematology, serum chemistry, 75g OGTT.
Gene expression profiling of peripheral blood cells.
To analyze the association between gene excretion and biomarkers over an 8-year period.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who received physical examination at Ishikawa Matto Central Hospital.
Patients who underwent a 75 g oral glucose tolerance test (75 g OGTT) at 0 years and 8 years.
patients with diabetes, hypertension, dyslipidemia, etc.
Patients provided written informed consent before participation
Key exclusion criteria
Pregnant women.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Toshinari |
| Middle name | |
| Last name | Takamura |
Organization
Kanazawa university
Division name
Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences
Zip code
920-8641
Address
13-1 Takaramachi Kanazawa-shi Ishikawa 920-8641 Japan
TEL
076-265-2234
ttakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Toshinari |
| Middle name | |
| Last name | Takamura |
Organization
Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences
Division name
Endocrinology & Metabolism
Zip code
920-8641
Address
13-1 Takaramachi Kanazawa-shi Ishikawa 920-8641 Japan
TEL
076-265-2234
Homepage URL
ttakamura@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa university
Institute
Department
Personal name
Funding Source
Organization
Kanazawa university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Reserch Center, Kanazawa University
Address
13-1 Takaramachi Kanazawa-shi Ishikawa 920-8641 Japan
Tel
076-265-2048
hpsangak@adm.kanazawa-u.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
公立松任石川中央病院/Public Central Hospital of Matto Ishikawa
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
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
| 2007 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Establishment of a new method to evaluate medical diseases by whole genome analysis and gene expression profiling using peripheral leukocytes
Management information
Registered date
| 2023 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057491
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| Registered date | File name |
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