UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060943 |
|---|---|
| Receipt number | R000069747 |
| Scientific Title | Prospective follow-up study of small bowel involvement using capsule endoscopy in newly diagnosed CD patients (PASSAGE-CD) |
| Date of disclosure of the study information | 2026/03/16 |
| Last modified on | 2026/03/16 14:36:22 |
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Basic information
Public title
Prospective follow-up study of small bowel involvement using capsule endoscopy in newly diagnosed CD patients (PASSAGE-CD)
Acronym
PASSAGE-CD
Scientific Title
Prospective follow-up study of small bowel involvement using capsule endoscopy in newly diagnosed CD patients (PASSAGE-CD)
Scientific Title:Acronym
PASSAGE-CD
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the clinical significance of small intestinal lesions, particularly those characteristic of early-stage CD, by tracking their serial progression using SBCE from the time of the initial CD diagnosis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the serial changes in small intestinal lesions in initially diagnosed CD
Key secondary outcomes
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
| 12 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who have not yet started advanced treatment within two years of receiving a definitive diagnosis of Crohn's disease
2. Patients who have not received a definitive diagnosis of Crohn's disease but are strongly suspected of having it
Key exclusion criteria
1. Patients in whom gastrointestinal patency cannot be confirmed using a pre-examination patency capsule
2. Patients with gastrointestinal fistulas
3. Patients with gastrointestinal motility disorders
4. Patients under 12 years of age or 75 years of age or older
5. Patients with an implanted pacemaker
6. Patients taking NSAIDs (including aspirin) on a regular basis
7. Individuals with concurrent malignant tumors, psychiatric disorders, or severe (very serious) liver, kidney, heart, or hematopoietic system disorders
8. Pregnant women, women who may be pregnant, breastfeeding women, or women who wish to become pregnant during the study period
9. Any other cases where the study investigator determines that participation in this study is inappropriate
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Esaki |
Organization
Saga University
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
849-8501
Address
Nabeshima 5-1-1, Saga
TEL
0952342361
mesaki01@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Ishibashi |
Organization
Saga University
Division name
Clinical Research Center
Zip code
849-8501
Address
Nabeshima 5-1-1, Saga
TEL
0952-34-3193
Homepage URL
dshelpdesk@ml.cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Saga University Hospital
Address
Nabeshima 5-1-1, Saga
Tel
0952-34-3357
sy7923@cc.saga-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
| 2026 | Year | 03 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) After obtaining consent to participate in this study, patient information is entered into the EDC, eligibility criteria are assessed, and case registration is finalized.
2) Clinical data at the time of registration and at each evaluation point are entered into the EDC in a pseudonymized form.
3) Imaging data (SBCE and upper and lower gastrointestinal endoscopy) and specimens (blood, stool, and urine) are sent to the study secretariat in a pseudonymized form and managed there. Subsequently, the specimens will be sent in bulk to the testing facility (SRL) and discarded after analysis.
4) Clinical data entry into the EDC, SBCE image data, and specimen collection will be performed a total of four times over a three-year period following the CD diagnosis.
5) Five years after the CD diagnosis, information regarding hospitalizations and intestinal resections related to CD will be collected.
Management information
Registered date
| 2026 | Year | 03 | Month | 16 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069747
