UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021460 |
|---|---|
| Receipt number | R000024710 |
| Scientific Title | Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer. |
| Date of disclosure of the study information | 2016/03/13 |
| Last modified on | 2020/11/06 19:16:46 |
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Basic information
Public title
Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer.
Acronym
Chromoendoscopy of colitic cancer using an acetic acid indigocarmine mixture
Scientific Title
Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer.
Scientific Title:Acronym
Chromoendoscopy of colitic cancer using an acetic acid indigocarmine mixture
Region
| Japan |
Condition
Condition
patients with ulcerative colitis had high risk of colitic cancer.
A:patients suspected dysplasia(low/high grade) or cancer.
B:patients had plan of treatment of the dysplasia or cancer.
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study was to evaluate the usefulness of AIM for diagnosed colitic cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of detected colitic cancer or dysplasia, comparison using white light between using AIM.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
40mL AIM solution (0.6% acetic acid with 0.4% IC) was sprinkled onto the lesions and images were recorded.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients with ulcerative colitis(UC) in clinical remission.
2.Patients visits within a year.
3.Patients who have underwent colonoscopy as UC surveillance.
4.Patients with UC in remission (Mayo score <2)
5.Patients had dysplasia or/and cancer.
6.Patient age is 20 years of age
7.Patients with informed consent.
Key exclusion criteria
1.Patients with a history that has received the surgical operation of UC.
2.Pregnant patients.
3.Patients who are breast-feeding.
4.Patients who have been the administration of the other study drug or investigational drugs within three months before the start of the administration of the study drug.
5.Patients has determined that inappropriate by principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakiko Hiraoka |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7219
sakikoh@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YuusakuSugihara |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7219
Homepage URL
y.sugi117@gmail.com
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 13 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 13 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024710
