UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059411 |
|---|---|
| Receipt number | R000067946 |
| Scientific Title | Study for Determining the LRG Cut-off Value Demonstrating Endoscopic Remission of Small-Bowel Lesions in Crohns Disease |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/15 10:05:38 |
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Basic information
Public title
Balloon-assisted Enteroscopy for Assessment and Correlation with biomarkers in small bowel Crohn's disease
Acronym
BEACON study
Scientific Title
Study for Determining the LRG Cut-off Value Demonstrating Endoscopic Remission of Small-Bowel Lesions in Crohns Disease
Scientific Title:Acronym
BEACON study
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between small bowel lesion activity assessed by balloon assisted enteroscopy and biomarkers including serum LRG as well as stool and urine biomarkers and to validate cut off values that enable estimation of the presence and activity of small bowel lesions.
Basic objectives2
Others
Basic objectives -Others
We will analyze the association between the presence and activity of small bowel lesions observed endoscopically and biomarker levels serum, stool, and urine including LRG. Our aim is to establish practical biomarker indices for the noninvasive estimation of smallbowel lesions. This represents a critical step in maintaining a Treat-to-Target (T2T) approach while avoiding invasive procedures and carries substantial social value by reducing patients physical and economic burden in addition to its scientific significance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of LRG (cut-off 10.5) for ulcerative small-bowel lesions (segmental modified SES-CD maximum 4)
Key secondary outcomes
Evaluate the diagnostic performance of serum, stool, and urine biomarkers for ulcerative small bowel lesions using ROC analysis and contingency tables.
Assess correlations between endoscopic scores and serum/stool/urine biomarkers.
Examine the relationship between endoscopic findings and serum/stool/urine biomarkers and patient prognosis using the Kaplan Meier method.
Investigate changes in diagnostic performance for ulcerative small-bowel lesions when combining multiple biomarkers.
Perform stratified (subgroup) analyses of the above primary and secondary endpoints by patient background characteristics.
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
Individuals diagnosed with ileal or ileocolonic type Crohn's disease.
Individuals scheduled to undergo balloon assisted enteroscopy for lesion assessment.
Individuals who provide informed consent to participate and for whom biomarker measurements can be obtained.
Key exclusion criteria
Individuals diagnosed with colonic type Crohn's disease.
Individuals with evident active perianal disease or perianal abscess.
Individuals with conditions contraindicating balloon assisted enteroscopy.
Individuals with malignancy; active infections (including the common cold); chronic inflammatory diseases (e.g., rheumatoid arthritis); or other serious comorbidities (e.g., hepatic or renal failure).
Individuals who have taken NSAIDs within the past 1 week.
Individuals who have taken stimulant laxatives within the past 1 week.
Individuals within 3 months of initiating biologic or JAK inhibitor therapy.
Pregnant or lactating individuals.
Any other individuals deemed unsuitable by the principal investigators.
Target sample size
243
Research contact person
Name of lead principal investigator
| 1st name | Kento |
| Middle name | |
| Last name | Takenaka |
Organization
Science Tokyo
Division name
Gastroenterology and Hepatology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5877
ktakenaka.gast@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Takenaka |
Organization
Science Tokyo
Division name
Gastroenterology and Hepatology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5877
Homepage URL
ktakenaka.gast@tmd.ac.jp
Sponsor or person
Institute
Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
NA
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
Science Tokyo University Center for Bioethics
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5877
admbec@tmd.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
| 2025 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067946
