UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048947 |
|---|---|
| Receipt number | R000055736 |
| Scientific Title | Survey on the correlation between drinking habits and plasma cell-free DNA concentrations |
| Date of disclosure of the study information | 2022/09/19 |
| Last modified on | 2023/03/20 17:49:56 |
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Basic information
Public title
Survey on the correlation between drinking habits and plasma cell-free DNA concentrations
Acronym
Survey on the correlation between drinking habits and plasma cell-free DNA concentrations
Scientific Title
Survey on the correlation between drinking habits and plasma cell-free DNA concentrations
Scientific Title:Acronym
Survey on the correlation between drinking habits and plasma cell-free DNA concentrations
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the relationship between plasma cell-free DNA concentrations and daily drinking habits in healthy adult male and female between 20 and less than 65 years old.
Basic objectives2
Others
Basic objectives -Others
Survey on the correlation between drinking habits and plasma cell-free DNA concentrations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Specific blood test(cell-free DNA), drinking habits
Key secondary outcomes
(Secondary outcomes)
Blood biochemistry test, lactic acid, pyruvic acid, amino acid, ADH1B and ALDH2 gene polymorphisms, smoking habits, exercise habits
(Safety evaluation)
adverse events
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy adult male and female between 20 and less than 65 years old.
2) Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing.
Key exclusion criteria
1) Subject who tests positive for hepatitis B antigen test.
2) Subject who has blood collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the start of the study.
3) Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Oshima |
Organization
Asahi Quality & Innovations, Ltd.
Division name
Sustainable Technology Laboratories
Zip code
302-0106
Address
1-21, Midori 1-Chome, Moriya-Shi, Ibaraki, Japan
TEL
0297-46-9351
shunji.oshima@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Oshima |
Organization
Asahi Quality & Innovations, Ltd.
Division name
Sustainable Technology Laboratories
Zip code
302-0106
Address
1-21, Midori 1-Chome, Moriya-Shi, Ibaraki, Japan
TEL
0297-46-9351
Homepage URL
shunji.oshima@asahi-qi.co.jp
Sponsor or person
Institute
Asahi Quality & Innovations, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, Ltd.
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
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga, Setagaya-ku, Tokyo, 158-0097 Japan
Tel
03-5491-4478
jim@medipharma.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
| 2022 | Year | 09 | Month | 19 | 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
98
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
| 2022 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 05 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 05 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 10 | Day |
Other
Other related information
The objective of this study is to investigate the relationship between plasma cell-free DNA concentrations and daily drinking habits in healthy adult male and female between 20 and less than 65 years old.
Management information
Registered date
| 2022 | Year | 09 | Month | 16 | Day |
Last modified on
| 2023 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055736
| Research Plan | |
|---|---|
| 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 |
