UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049340 |
|---|---|
| Receipt number | R000056191 |
| Scientific Title | Polyunsaturated fatty acids, trans fatty acids, and colorectal cancer incidence: a systematic review and a meta-analysis |
| Date of disclosure of the study information | 2022/10/27 |
| Last modified on | 2026/04/04 22:17:02 |
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Basic information
Public title
Polyunsaturated fatty acids, trans fatty acids, and colorectal cancer
incidence: a systematic review and a meta-analysis
Acronym
Polyunsaturated fatty acids, trans fatty acids, and colorectal cancer
incidence: a systematic review and a meta-analysis
Scientific Title
Polyunsaturated fatty acids, trans fatty acids, and colorectal cancer
incidence: a systematic review and a meta-analysis
Scientific Title:Acronym
Polyunsaturated fatty acids, trans fatty acids, and colorectal cancer
incidence: a systematic review and a meta-analysis
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is not clear whether n-6 or n-3 polyunsaturated fatty acids and trans-unsaturated fatty acids are associated with the development of colorectal cancer. A systematic review and meta-analysis of whether exposure to individual n-3 and n-6 polyunsaturated fatty acids and their combinations and individual trans-unsaturated fatty acids and their combinations affect colorectal cancer development, including dietary assessment methods and biomarker types.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Colorectal cancer incidence, Colorectal tumor incidence
Key secondary outcomes
Colon, or rectum cancer incidence, Colon, or rectum tumor incidence
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 years or older at risk of developing colorectal cancer
Key exclusion criteria
NA
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tomiyo |
| Middle name | |
| Last name | Nakamura |
Organization
Ryukoku University
Division name
Research Center for Food Preference
Zip code
520-2194
Address
1-5,Yokotani, Seta Oe-cho, Otsu, Shiga, Japan
TEL
077-543-7742
pe-nakamura-to@mail.ryukoku.ac.jp
Public contact
Name of contact person
| 1st name | Tomiyo |
| Middle name | |
| Last name | Nakamura |
Organization
Ryukoku University
Division name
Research Center for Food Preference
Zip code
5202194
Address
1-5,Yokotani, Seta Oe-cho,Otsu, Shiga, Japan
TEL
077-543-7742
Homepage URL
pe-nakamura-to@mail.ryukoku.ac.jp
Sponsor or person
Institute
Ryukoku University
Institute
Department
Personal name
Funding Source
Organization
Ryukoku University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rytukoku University Ethics Committee
Address
67 Tsukamoto-cho, Fukakusa Fushimi-ku,Kyoto, Kyoto, Japan
Tel
0756457875
hitorinri-jim@ad.ryukoku.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
361971
Org. issuing International ID_1
PROSPERO
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 | 10 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 23 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Search strategy:
We will conduct a systematic review and meta-analysis in according with review and meta-analysis in according with PRISMA statement. We will search databases(MEDLINE, Embase, Ovid, the Cochrane Library, J-stage).
Strategy for data synthesis:
Identify sets of the fatty acid exposures that allow meta-analysis with 5 estimates or more. Meta-analyses will include random-effects meta-analysis for categories of PUFA exposures, a linear dose-response meta-analysis, and non-linear dose-response meta-analysis. Biomarkers and dietary intakes will be separated. Relative risk and 95% confidence intervals will be estimated after harmonisation of exposure levels and corresponding association measures.
Meta-regression will be performed to identify any heterogeneity of associations by population characteristics .
We will attempt to obtain additional information by contacting authors of published articles so that we do not need to exposure because of missing information that should have been reported.
Management information
Registered date
| 2022 | Year | 10 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056191
