UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042730 |
|---|---|
| Receipt number | R000048778 |
| Scientific Title | Evaluation of the Usefulness of Texture and Color Enhancement Imaging (TXI) for Activity Assessment in Ulcerative Colitis |
| Date of disclosure of the study information | 2020/12/11 |
| Last modified on | 2023/10/13 12:24:26 |
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Basic information
Public title
Evaluation of the Usefulness of Texture and Color Enhancement Imaging (TXI) for Activity Assessment in Ulcerative Colitis
Acronym
Evaluation of the Usefulness of Texture and Color Enhancement Imaging (TXI) for Activity Assessment in Ulcerative Colitis
Scientific Title
Evaluation of the Usefulness of Texture and Color Enhancement Imaging (TXI) for Activity Assessment in Ulcerative Colitis
Scientific Title:Acronym
Evaluation of the Usefulness of Texture and Color Enhancement Imaging (TXI) for Activity Assessment in Ulcerative Colitis
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of Texture and Color Enhancement Imaging (TXI), a structural color enhancement feature, in assessing the activity of ulcerative colitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between inflammation assessment and relapse using TXI in ulcerative colitis
Key secondary outcomes
Correlation between inflammation assessment by TXI and RDI, Mayo endoscopic score, and pathology score (Geboes index),Inter-observer agreement between inflammation assessment by TXI and RDI, Mayo endoscopic score, and pathology score (Geboes index).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been previously diagnosed with ulcerative colitis
Patients who will undergo lower gastrointestinal endoscopy due to clinical necessity
Key exclusion criteria
Patients undergoing lower gastrointestinal endoscopy without prior treatment
Patients with or suspected of having intestinal obstruction, stenosis, fistula, post-operative colorectal surgery, infectious enteritis, or active colonic bleeding.
Patients with a history of radiation therapy to the abdomen or pelvis
Tissue biopsy is not possible (e.g., chronic blood disease or taking anticoagulant or antiplatelet drugs)
Patients who do not consent to this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Takabayashi |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0333531211
kaoru0902@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Hayashi |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0333531211
Homepage URL
yukie_tennis_0929@yahoo.co.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3760
med-rinri-jimu@adst.keio.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
| 2020 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
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
| 2020 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2020 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048778
