UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053890 |
|---|---|
| Receipt number | R000061026 |
| Scientific Title | Effectiveness of rapid reporting and reservation service of fecal immunochemical test for colorectal cancer screening |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/18 16:02:38 |
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Basic information
Public title
Effectiveness of rapid reporting and reservation service of fecal immunochemical test for colorectal cancer screening
Acronym
Effectiveness of rapid reporting and reservation service of fecal immunochemical test for colorectal cancer screening
Scientific Title
Effectiveness of rapid reporting and reservation service of fecal immunochemical test for colorectal cancer screening
Scientific Title:Acronym
Effectiveness of rapid reporting and reservation service of fecal immunochemical test for colorectal cancer screening
Region
| Japan |
Condition
Condition
Healthy adults undergoing fecal immunochemical test for colorectal cancer screening
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether a service that provides immediate notification of positive results of fecal immunochemical test and a subsequent appointment for a colonoscopy would increase the proportion of the subjects who actually receive a colonoscopy in total participants of colorectal cancer screening.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of participants with positive result of fecal immunochemical test undergoing colonoscopy or colon CT within 24 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Providing a service for reporting positive The fecal immunochemical test (FIT) results and scheduling assistance for colonoscopies
Interventions/Control_2
Providing positive FIT result via mail.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria include individuals aged >18 years with a positive FIT result for colorectal cancer screening.
Key exclusion criteria
Exclusion criteria encompass those with a history of colorectal cancer or chronic colorectal disease, or who have undergone a colonoscopy within the past two years.
Target sample size
336
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University School of Public Health
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshidahonmachi, Sakyo-ku, Kyoto city
TEL
075-753-7531
hhonda0703@gmail.com
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Honda |
Organization
Kyoto University School of Public Health
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshidahonmachi, Sakyo-ku, Kyoto city
TEL
075-753-7531
Homepage URL
hhonda0703@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
| 2024 | Year | 04 | Month | 01 | 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
| 2023 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061026
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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