UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049187 |
|---|---|
| Receipt number | R000056026 |
| Scientific Title | A new time-related benchmark for the adenoma detection rate in the second surveillance colonoscopy following the fecal immunochemical test |
| Date of disclosure of the study information | 2022/10/12 |
| Last modified on | 2022/10/25 22:37:58 |
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Basic information
Public title
A new time-related benchmark for the adenoma detection rate in the second surveillance colonoscopy following the fecal immunochemical test
Acronym
A new time-related benchmark for the adenoma detection rate in the second surveillance colonoscopy following the fecal immunochemical test
Scientific Title
A new time-related benchmark for the adenoma detection rate in the second surveillance colonoscopy following the fecal immunochemical test
Scientific Title:Acronym
A novel time-related indicator for ADR
Region
| Japan |
Condition
Condition
Colonic adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical impact of stratified combined benchmark of observation time (t-OBS) with t-OBS/ intubation time (t-INT) ratio on the detection of colonic adenomas.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Impact of time-related indicator stratified by t-OBS and t-OBS/ t-INT ratio on ADR.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients ;
age 20 years old and more
underwent FIT
underwent CS
submitted written consent.
Key exclusion criteria
Patients;
with previous colorectal resection
with already known colonic malignancy
without bowel preparation
with unavailable valuables of primary endpoint.
Target sample size
369
Research contact person
Name of lead principal investigator
| 1st name | TESSHIN |
| Middle name | |
| Last name | BAN |
Organization
Gamagori City Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
443-8501
Address
1-1 Mukaida, Hirata, Gamagori
TEL
0533662200
venzosan0204@gmail.com
Public contact
Name of contact person
| 1st name | TESSHIN |
| Middle name | |
| Last name | BAN |
Organization
Gamagori City Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
443-8501
Address
1-1 Mukaida, Hirata, Gamagori
TEL
0533662200
Homepage URL
venzosan0204@gmail.com
Sponsor or person
Institute
Gamagori City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gamagori City Hospital
Address
1-1 Mukaida, Hirata, Gamagori
Tel
0533662200
venzosan0204@gmail.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 12 | 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 | 06 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056026
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/10/25 | FIT_CS_ADR_ UMIN.xlsx |
