UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050970 |
|---|---|
| Receipt number | R000058020 |
| Scientific Title | SOnographic evaLuation for Inflammatory bowel disease in Daily practice (SOLID) Study |
| Date of disclosure of the study information | 2023/05/05 |
| Last modified on | 2025/01/24 14:05:04 |
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Basic information
Public title
SOnographic evaLuation for Inflammatory bowel disease in Daily practice (SOLID) Study
Acronym
SOLID Study
Scientific Title
SOnographic evaLuation for Inflammatory bowel disease in Daily practice (SOLID) Study
Scientific Title:Acronym
SOLID Study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the reliability of intestinal ultrasound (IUS), which is a non-invasive examination for assessing the disease activity of ulcerative colitis (UC), and to develop a scoring system to estimate endoscopic remission, which is a therapeutic goal of UC, based on IUS findings.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimation accuracy of a scoring system based on IUS findings developed in this study (SOLID-UC index) for endoscopic remission at 6 months after starting the remission induction therapy.
Key secondary outcomes
- Intra-/inter-observer agreement rates of each sonographic parameter in each segment of the colon and in the most severely affected part of the colon
- Minimal important change of SOLID-UC index
- Correlation between changes in SOLID-UC index, in its parameters, and in endoscopic scores
- Assessment of reliability and measurement error of SOLID-UC index
- Comparison of the predictive accuracy of SOLID-UC index, partial Mayo score, Lichtiger index, and biomarkers for endoscopic remission at 6 months after remission induction treatment
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Subjects diagnosed with UC.
- Subjects who plan to take endoscopic examinations for assessing the disease activity of UC in daily practice.
- Subjects who are 16 years old or older when providing written consent.
- Subjects who understand, decide to take part in this study and provide written consent by themselves. Minors need consent from themselves as well as their guardians.
Key exclusion criteria
- Subjects who had total or partial colectomy or plan to take such surgery when providing written consent.
- Subjects diagnosed with proctitis or an undetermined disease type.
- Subjects with suspected concomitant colitis, e.g. infections enteritis, diverticulitis, and ischemic colitis (taking colonoscopy for examining other etiologies).
- Subjects with an emergent, critical condition of UC.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Miyoshi |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
jmiyoshi@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Miyoshi |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
Homepage URL
jmiyoshi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Jun Miyoshi
Funding Source
Organization
Self-funding
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
杏林大学医学部（東京都）、北里大学北里研究所病院炎症性腸疾患先進治療センター（東京都）、札幌医科大学附属病院（北海道）、滋賀医科大学（滋賀県）、京都大学大学院医学研究科（京都府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 05 | 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
| 2023 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study aims to assess the reliability of IUS, a non-invasive examination for evaluating UC disease activity, and to develop a simple practical scoring system to predict endoscopic remission, one of today's therapeutic goals in UC.
Management information
Registered date
| 2023 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058020
