UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030412 |
|---|---|
| Receipt number | R000034422 |
| Scientific Title | Scores evaluation for observation of Ulcerative colitis using linked color imaging |
| Date of disclosure of the study information | 2017/12/23 |
| Last modified on | 2020/06/17 09:27:03 |
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Basic information
Public title
Scores evaluation for observation of Ulcerative colitis using linked color imaging
Acronym
SOUL study
Scientific Title
Scores evaluation for observation of Ulcerative colitis using linked color imaging
Scientific Title:Acronym
SOUL study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims at improving patients' QOL, disease management, and contributing to the medical economy by establishing new evaluation method in ulcerative colitis in an endoscopic system equipped with a new image enhancement system called LCI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between redness, lymph follicles, inflammation range in LCI and histpathological diagnosis with Geboes score
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform colonoscopy, observe and photograph in LCI and white light, and perform biopsy
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis in clinical remission and Mayo endoscopic subscore 0 or 1
Key exclusion criteria
Patients undergoing total colonectomy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadakazu |
| Middle name | |
| Last name | Hisamatsu |
Organization
Kyorin University School of Medicine
Division name
Third Department of Internal Medicine
Zip code
1818611
Address
Shinkawa 6-20-2, Mitaka, Tokyo, Japan
TEL
0422475511
thisamatsu@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Saito |
| Middle name | |
| Last name | Daisuke |
Organization
Kyorin University School of Medicine
Division name
Third Department of Internal Medicine
Zip code
1818611
Address
Shinkawa 6-20-2, Mitaka, Tokyo, Japan
TEL
0422475511
Homepage URL
straw@zb3.so-net.ne.jp
Sponsor or person
Institute
Third Department of Internal Medicine, Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Third Department of Internal Medicine, Kyorin University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University School of Medicine
Address
6-20-2 Shinkawa
Tel
0422475511
straw@zb3.so-net.ne.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
| 2017 | Year | 12 | Month | 23 | 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
| 2017 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2020 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034422
