UMIN-CTR Clinical Trial

Basic information
Public title	Monitoring examination of the lifestyle-related disease prevention
Acronym	Monitoring examination of the lifestyle-related disease prevention
Scientific Title	Monitoring examination of the lifestyle-related disease prevention
Scientific Title:Acronym	Monitoring examination of the lifestyle-related disease prevention
Region	Japan

Condition
Condition	Lifestyle-related disease prevention
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Self-administration of the lifestyle-related disease prevention
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Urinalysis and blood test
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Volunteer
Key exclusion criteria	Illness person
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Yohei Middle name Last name Kanazawa
Organization	First Screening Corp.
Division name	Board
Zip code	151-0053
Address	1-30-14 Yoyogi Shibuya Tokyo
TEL	050-3631-7556
Email	kanazawa@first-screening.com

Public contact
Name of contact person	1st name Tetsuro Middle name Last name Ieda
Organization	Board
Division name	Board
Zip code	151-0053
Address	1-30-14 Yoyogi Shibuya Tokyo
TEL	050-3631-7556
Homepage URL
Email	ieda@first-screening.com

Sponsor
Institute	First Screening Corp.
Institute
Department

Funding Source
Organization	First Screening Corp.
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	SOUKEN
Address	1-9-10 Hamamatsu-Cho, Minatoku, Tokyo
Tel	050-3390-9275
Email	y_huzita@mail.souken-r.com

Secondary IDs
Secondary IDs	YES
Study ID_1	150418_rn-33368
Org. issuing International ID_1	Shiba Palace Clinic
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2023 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	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	2022 Year 08 Month 31 Day
Date of IRB	2022 Year 09 Month 01 Day
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Urinalysis and blood test

Management information
Registered date	2022 Year 10 Month 28 Day
Last modified on	2022 Year 10 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056200