UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043178 |
|---|---|
| Receipt number | R000049285 |
| Scientific Title | Colonoscopic Randomized Clinical Trial for TXI-use additional 30-seconds observation for preventing missed polyps |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/05/02 00:58:28 |
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Basic information
Public title
Colonoscopic Randomized Clinical Trial for TXI-use additional 30-seconds observation for preventing missed polyps
Acronym
COLT-30 study
Scientific Title
Colonoscopic Randomized Clinical Trial for TXI-use additional 30-seconds observation for preventing missed polyps
Scientific Title:Acronym
COLT-30 study
Region
| Japan |
Condition
Condition
colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the non-inferiority of additional 30-seconds observation with texture and color enhancement imaging compared to that with narrow band imaging for preventing missed polyps
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
neoplastic polyp number (adenoma and sessile serrated lesion) per patient detected with additional 30-seconds observation of TXI and NBI
Key secondary outcomes
In the TXI and NBI groups,
polyp detection rate with additional 30-seconds observation
adenoma and sessile serrated lesion number with additional 30-seconds observation
adenoma and sessile serrated lesion detection rate with additional 30-seconds observation
The increase of adenoma and sessile serrate lesions in first and second observation compared to first observation
The efficacy of addtional 30 seconds observation according to status of bowel preparation, types of endoscopes, endoscopist lvel
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
TXI observation for additional 30 secs observation
Interventions/Control_2
NBI observation for additional 30 secs observation
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
age over 40 years
1. various symptoms such as abdominal pain, constipation, anemia, and hematochezia
2. surveillance after polyp or cancer resection
3. positive fecal occult blood
4. screening
Key exclusion criteria
1) surgical resection of right-sided colon
2) Familial adenomatous polyposis
3) Inflammatory bowel syndrome
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | Naohisa |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
naohisa@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Naohisa |
| Middle name | |
| Last name | Yoshida |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
naohisa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Gastroenterology, Kyoto First Red Cross Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5519
naohisa@koto.kpu-m.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
京都府立医科大学(京都府)、京都第一赤十字病院(京都府)、西陣病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049285
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/05/02 | revised COLT 20220117 研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/05/02 | COLT study ポリープdataシート20210922.docx |
| Research case data | |
|---|---|
| Registered date | File name |
