UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049978 |
|---|---|
| Receipt number | R000056927 |
| Scientific Title | A multicenter observational study for measurement of SNPs in participants of the Japan Polyp Study Cohort |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2023/01/06 17:01:56 |
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Basic information
Public title
A multicenter observational study for measurement of SNPs in participants of the Japan Polyp Study Cohort
Acronym
JPS Cohort SNP measurement study
Scientific Title
A multicenter observational study for measurement of SNPs in participants of the Japan Polyp Study Cohort
Scientific Title:Acronym
JPS Cohort SNP measurement study
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine risk factors for the development of colorectal carcinoma focusing on single-nucleotide polymorphisms (SNPs) in patients with a history of colorectal cancer and assess how the SNPs modify the effectiveness of aspirin in preventing colorectal cancer using the data from J-CAPP Study II as a historical control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Interaction between SNPs of ALDH2 and the effectiveness of aspirin in preventing the development of index lesions (ILs: cancers, adenomas with high-grade dysplasia, and adenomas measuring >= 10 mm) at 4 years
Key secondary outcomes
1) Interaction between SNPs of ADH1B and the effectiveness of aspirin in preventing the development of ILs at 4 years
2) Interaction between SNPs of CYP2A6 and the effectiveness of aspirin in preventing the development of ILs at 4 years
3) Impacts of SNPs of ALDH2, ADH1B, and CYP2A6 on the development of ILs and adenomas within the JPS Cohort
4) Interaction between SNPs of ALDH2 and the effectiveness of aspirin in preventing the development of adenomas at 4 years
5) Interaction between SNPs of ADH1B and the effectiveness of aspirin in preventing the development of adenomas at 4 years
6) Interaction between SNPs of CYP2A6 and the effectiveness of aspirin in preventing the development of adenomas at 4 years
7) Analyses of 1) to 6) taking into account the age, sex, alcohol intake, smoking, height, and body weight
8) Analyses of 1) to 6) using the site, size, and morphology of colorectal cancer as endpoints
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who consented to participate in the JPS Cohort and have not withdrawn their consent.
Key exclusion criteria
non
Target sample size
1230
Research contact person
Name of lead principal investigator
| 1st name | Kobayashi |
| Middle name | |
| Last name | Nozomu |
Organization
National Cancer Center Hospital
Division name
Cancer Screening Center/ Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
0335422511
nokobaya@ncc.go.jp
Public contact
Name of contact person
| 1st name | Nozomu |
| Middle name | |
| Last name | Kobayashi |
Organization
National Cancer Center Hospital
Division name
Cancer Screening Center/ Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
0335422511
Homepage URL
nokobaya@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
ncch-irb@ml.res.ncc.go.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
| 2023 | Year | 01 | Month | 10 | 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
| 2022 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Methods
1) After written informed consent is obtained, 0.3 mL of blood is collected from each subject and processed using the dried blood spot method.
2) The specimens are sent by mail to the Department of Public Health, Wakayama Medical University.
3) SNPs of aldehyde dehydrogenase 2 (ALDH2), alcohol dehydrogenase 1B (ADH1B), and cytochrome P450 2A6 (CYP2A6) are measured, and the results are provided with an explanatory booklet for those who wish.
4) Other SNPs, if deemed necessary, are measured after approval by the Ethical Review Board.
Management information
Registered date
| 2023 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056927
| 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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