UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053593 |
|---|---|
| Receipt number | R000061157 |
| Scientific Title | Is ADvanced transPerineaL UltraSonography in ulcerative colitis useful for predicting the response to induction therapy? (ADPLUS study) |
| Date of disclosure of the study information | 2024/02/10 |
| Last modified on | 2024/02/10 18:45:28 |
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Basic information
Public title
Exploring Ultrasound Innovations for Predicting Treatment Success in Severe Ulcerative Colitis
Acronym
Advanced Intestinal Ultrasound's Utility in Ulcerative Colitis
Scientific Title
Is ADvanced transPerineaL UltraSonography in ulcerative colitis useful for predicting the response to induction therapy? (ADPLUS study)
Scientific Title:Acronym
ADPLUS study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary goal is to investigate whether the baseline in advanced transperineal ultrasonography of the induction therapy is a long-term prognosis predictor compared with endoscopic findings in ulcerative colitis.
Basic objectives2
Others
Basic objectives -Others
The secondary goal is to predict pathological findings taken simultaneously with endoscopy, and ultimately, by monitoring with ultrasound examination early after treatment, to explore TPUS findings that can predict treatment prognosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary Endpoint:
Predictor: Remission at 24 weeks (defined as meeting all criteria for clinical remission, endoscopic improvement, and histological improvement)
Definitions of Remission and Improvement:
Endoscopic mucosal healing: Mayo endoscopic subscore=0
Endoscopic improvement: Mayo endoscopic subscore<2
Clinical remission: Defined as no rectal bleeding (PRO2 subscore=0) and a total PRO2<2
Ultrasound remission: Normal total colonic wall thickness and blood flow score<2
Histological mucosal improvement: Nancy index<=1, Geboes score<3.1
Evaluation of the degree of fibrosis:
Improvement in urgency: Improvement of NRS>1
Disease clearance: clinical (partial-Mayo score<3), endoscopic (endoscopic-Mayo score=0), and histological (Nancy index=0)
Key secondary outcomes
Secondary Endpoints:
Endoscopic mucosal healing and improvement at 24 weeks
Clinical remission after 2 weeks, 14 weeks, and 24 weeks
Ultrasound remission after 24 weeks
Histological mucosal healing at 24 weeks: Nancy index <2
Correlation between endoscopic findings, urgency, and incontinence scores at baseline, after 2 weeks, 14 weeks, and 24 weeks
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants: Patients with ulcerative colitis (UC) in remission and active phases
Implementation Timing: For patients in remission, at the time of endoscopy; for patients in the active phase, at the start of induction therapy, then 2 weeks, 14 weeks, and 24 weeks after
Key exclusion criteria
-Patients who have undergone colectomy
-Pregnant patients
-Among patients with active disease undergoing remission induction therapy, patients receiving remission induction therapy for extraintestinal complications rather than intestinal inflammation
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Sagami |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL
0334446161
jaken1013@gmail.com
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Sagami |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
TEL
03-3444-6161
Homepage URL
jaken1013@gmail.com
Sponsor or person
Institute
Shintaro Sagami, M.D., Ph.D.
Center for Advanced IBD Research and Treatment
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
ECCO-IBUS grant
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Kitasato Institute Hospital Research Ethics Committee Office
Address
5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan
Tel
03-3444-6161
kenkyu@insti.kitasato-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
| 2024 | Year | 02 | Month | 10 | 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 | 12 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigation Items
Ultrasonography
Fecal biomarkers: Tests conducted within 7 days before starting remission induction therapy or prior to colonoscopy, or within 3-7 days post-colonoscopy, or within 7 days before colonoscopy are considered. The items include fecal calprotectin (FC) and fecal occult blood test.
Patient background: Age, gender, age at onset, medication history, extent of affliction, duration of illness, family history, life history, past medical history, height, weight, comorbidities, past medical history, family history, smoking history, duration of affliction, disease pattern, treatment history, concomitant medications (names of drugs used during the study period, administration period), etc.
Blood biochemistry tests: WBC, Hb, Alb, SAA, CRP, LRG, ESR
Endoscopic evaluation: Mayo endoscopic subscore, the Ulcerative Colitis Endoscopic Index of Severity
Pathological histological examination: Assess fibrosis and inflammation
Clinical severity: Clinical scores to be considered include The Simple Clinical Colitis Activity (SCCAI), Mayo score, Lichtiger index, Modified Truelove and Witts' index.
Urgency of defecation (Numerical Rating Scale, NRS)
Management information
Registered date
| 2024 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061157
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