UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038731 |
|---|---|
| Receipt number | R000044123 |
| Scientific Title | Studies on non-invasive monitoring of lifestyle diseases |
| Date of disclosure of the study information | 2019/12/02 |
| Last modified on | 2020/01/09 09:58:47 |
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Basic information
Public title
Studies on non-invasive monitoring of lifestyle diseases
Acronym
Studies on non-invasive monitoring of lifestyle diseases
Scientific Title
Studies on non-invasive monitoring of lifestyle diseases
Scientific Title:Acronym
Studies on non-invasive monitoring of lifestyle diseases
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to collect data on blood ingredients, blood flow, and blood pressure by non-intrusive measurements, and to compare them with blood sampling data for lifestyle diseases patients, life-style diseases spare group, and healthy Japanese men and women over 20 years of age
Basic objectives2
Others
Basic objectives -Others
Comparison of non-invasive measurement data and blood sampling data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vital signs, Physical measurements, Blood test, Non-invasive measurements
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Japanese men and women aged 20 years or older at the time of the informed consent.
2)Subject whose values apply to reference value of life-style deseases by self-report
3)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria
1.Subject who is currently undergoing some kind of exercise, diet or medication.
2.Subject who has or had a history of either medicine or alcohol dependence syndrome.
3.Subject who has or had a history of mental illness (depression) or sleep disturbance.
4.Subject who is disease or history such severe diseases such as brain disease, malignant tumor, immune disease,liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases person.
5.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition.
6.Subject who carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition.
7.Subject who is currently pregnant or lactating, or planning to get pregnant.
8.Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
ochitani@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
NTT DOCOMO, INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihonbashi Sakura Clinic Research Ethics Committee
Address
1-9-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo Inamura Building 5F
Tel
03-5575-5862
c-irb_ug@neues.co.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 02 | 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
150
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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 24 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Crossing study
Management information
Registered date
| 2019 | Year | 11 | Month | 29 | Day |
Last modified on
| 2020 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044123
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
