UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043854 |
|---|---|
| Receipt number | R000050051 |
| Scientific Title | A multicenter, open-label, single-blind, randomized, parallel-group study to evaluate the utility of indigocarmine and acetic acid-indigocarmine mixture (AIM) for the diagnosis of colonic serrated lesions in the right side colon |
| Date of disclosure of the study information | 2021/04/14 |
| Last modified on | 2021/04/06 16:15:42 |
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Basic information
Public title
The usefulness of AIM in colonoscopy
Acronym
The usefulness of AIM in colonoscopy (cAIM study)
Scientific Title
A multicenter, open-label, single-blind, randomized, parallel-group study to evaluate the utility of indigocarmine and acetic acid-indigocarmine mixture (AIM) for the diagnosis of colonic serrated lesions in the right side colon
Scientific Title:Acronym
A multicenter, open-label, single-blind, randomized, parallel-group study to evaluate the utility of indigocarmine and acetic acid-indigocarmine mixture (AIM) for the diagnosis of colonic serrated lesions in the right side colon (cAIM study)
Region
| Japan |
Condition
Condition
Serrated lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of AIM
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Additional effect of AIM on detection of colonic serrated lesions including sessile serrated lesion(SSL)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
normal observation
Interventions/Control_2
observation with indigocarmine
Interventions/Control_3
observation with acetic acid-indigocarmine mixture(AIM)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are between 20 years and 90 years old at the time of obtaining consent
(2) A person for whom the patient's written consent has been obtained
(3) Patients who are scheduled for screening colonoscopy (e.g., fecal occult blood, cancer screening, and colonoscopy with no endoscopic treatment within 1 year)
Key exclusion criteria
(1) Familial colorectal adenomatosis, Lynch syndrome, serrated polyp syndrome(SPS)
(2) Patients with a history of colorectal cancer surgery
(3) Patients with endoscopic treatment of the colon within 1 year
(4) Ulcerative colitis and Crohn's disease
(5) Difficulty with endoscopic examination and treatment due to inability to temporarily stop taking antithrombotic or anticoagulant drugs
(6) Patents with an infectious disease that requires systemic treatment
(7) Pregnant and lactating women
(8) Patients with a history of hypersensitivity to indigocarmine or acetic acid
(9) Patients who are deemed unsuitable as research subjects by the principal investigator or sub-researcher
Target sample size
1311
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Kinugasa |
Organization
Okayama University Hospital
Division name
Department of endoscopy
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357219
hkinugasa14@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Kinugasa |
Organization
Okayama University Hospital
Division name
Department of endoscopy
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357219
Homepage URL
hkinugasa14@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
0862357219
hkinugasa14@okayama-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
| 2021 | Year | 04 | Month | 14 | 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
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2021 | Year | 04 | Month | 06 | Day |
Last modified on
| 2021 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050051
| 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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