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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039526
Receipt No. R000045077
Scientific Title A Study for the development of the method for cancer risk assessment using highly accurate genomic mutation analysis
Date of disclosure of the study information 2020/02/18
Last modified on 2020/02/18

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Basic information
Public title Development of a method for cancer risk assessment by genomic mutation analysis
Acronym Development of a method for cancer risk assessment by genomic mutation analysis
Scientific Title A Study for the development of the method for cancer risk assessment using highly accurate genomic mutation analysis
Scientific Title:Acronym Development of a method for cancer risk assessment by genomic mutation analysis
Region
Japan

Condition
Condition Healthy adults, Cancer patients
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To address the applicability of cancer risk assessment by analyzing the somatic genome mutations in gut and esophagus
Basic objectives2 Others
Basic objectives -Others o address the possibility
1. to estimate the history of exposures to environmental mutagens, or
2. to establish the method to assess risk of cancer onset
by analyzing the somatic mutations in non-cancerous gut or esophagus tissues
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of the patterns, frequencies, positions and distributions of somatic mutations
Key secondary outcomes 1. Estimation of relevant environmental mutagens by the evaluation of the patterns and frequencies, or sequence context of somatic mutations
2. Estimation of mutation acquiring processes by the evaluation of positions of mutations and correlations to known epigenetic markers

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
89 years-old >=
Gender Male and Female
Key inclusion criteria Healthy males and females
Key exclusion criteria Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 171

Research contact person
Name of lead principal investigator
1st name Naohiro
Middle name
Last name Ikeda
Organization Kao Corporation
Division name Safety Science Research
Zip code 210-0821
Address Innovation center of NanoMedicine (iCONM), 3-25-14, Tonomachi, kawasaki-ku, Kawasaki-shi, Kanagawa
TEL +81-80-8763-1214
Email ikeda.naohiro@kao.com

Public contact
Name of contact person
1st name Shoji
Middle name
Last name Matsumura
Organization Kao Corporation
Division name Safety Science Research
Zip code 210-0821
Address Innovation center of NanoMedicine (iCONM), 3-25-14, Tonomachi, kawasaki-ku, Kawasaki-shi, Kanagawa
TEL +81-70-3301-1852
Homepage URL
Email matsumura.shouji@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center Research Institute
Name of secondary funder(s)

IRB Contact (For public release)
Organization Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-7263
Email morisaki.naoko@kao.com

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 花王株式会社(神奈川県)

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 18 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
2019 Year 12 Month 20 Day
Date of IRB
2019 Year 12 Month 20 Day
Anticipated trial start date
2019 Year 12 Month 20 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To address the applicability of cancer risk assessment by analyzing the somatic genome mutations in gut and esophagus

Management information
Registered date
2020 Year 02 Month 18 Day
Last modified on
2020 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045077

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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