UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039526 |
|---|---|
| Receipt number | 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 18:17:35 |
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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
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
matsumura.shouji@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
