UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056350 |
|---|---|
| Receipt number | R000064377 |
| Scientific Title | A Multicenter Prospective Study for Image Collection and Evaluation to Assess the Simpler Diagnostic Algorithm of the Japan Esophageal Society Classification for Barrett's Esophagus-Related Superficial Neoplasia |
| Date of disclosure of the study information | 2024/12/04 |
| Last modified on | 2025/06/05 00:20:56 |
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Basic information
Public title
A Multicenter Prospective Study for Image Collection and Evaluation to Assess the Simpler Diagnostic Algorithm of the Japan Esophageal Society Classification for Barrett's Esophagus-Related Superficial Neoplasia
Acronym
JES-BE Simplified Study
Scientific Title
A Multicenter Prospective Study for Image Collection and Evaluation to Assess the Simpler Diagnostic Algorithm of the Japan Esophageal Society Classification for Barrett's Esophagus-Related Superficial Neoplasia
Scientific Title:Acronym
JES-BE Simplified Study
Region
| Japan |
Condition
Condition
Barrett's adenocarcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the utility of a novel simplified algorithm for the Japan Esophageal Society Barrett's Esophagus classification (JES-BE classification) using magnifying endoscopy, the primary endpoint will be the sensitivity for distinguishing between neoplastic and non-neoplastic (dysplastic and non-dysplastic) lesions, aiming to demonstrate non-inferiority compared to the conventional algorithm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity for diagnosing neoplastic and non-neoplastic (dysplastic and non-dysplastic) lesions
Key secondary outcomes
1. Diagnostic accuracy (specificity, accuracy, positive predictive value, negative predictive value)
2. Diagnostic reproducibility (inter- and intra-observer agreement)
3. Diagnostic accuracy and reproducibility stratified by confidence levels (low or high)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Participants must be aged 18 or older at enrollment.
2. Endoscopic examinations are conducted following ethics committee approval at each institution.
3. NBI magnifying endoscopy using a high-definition system (EVIS LUCERA or X1 light source and H260Z, H290Z, HQ290, XZ1200, or EZ1500 scopes with A8 or B8 settings) is performed for:
i. Screening/surveillance of Barrett's esophagus (Prague M1 or higher).
ii. Detailed examination before/during treatment for superficial Barrett's esophageal cancer.
4. Biopsy for distinguishing neoplastic or non-neoplastic lesions or endoscopic resection for treatment is conducted, allowing point by point comparison of images and pathology.
5. High-quality NBI magnified images (clear, focused, mucus, blood-free) of the evaluation site are preserved.
6. Captured images include:
i. Low magnification: Diagnosing mucosal structure (not vascular). For Dual Focus devices, images in Dual Focus mode are used.
ii. High magnification: Diagnosing vascular structure at full or near-full zoom. For Dual Focus devices, Dual Focus plus 1.4x zoom images are used.
iii. (Biopsy cases only) Images showing the magnified observation area matches the biopsy site.
7. Tumors must be flat lesions (0-IIa, IIb, IIc). Polypoid elevated lesions (0-I) and ulcerative lesions (0-III), which lack identifiable mucosal or vascular patterns, are excluded.
Key exclusion criteria
1. A history of chemotherapy or radiotherapy for esophageal squamous cell carcinoma.
2. Coexisting psychiatric disorders or mental symptoms that are deemed to make participation in the study difficult.
3. The investigator judges that enrollment in this study is inappropriate.
Target sample size
173
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Ishihara |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka, Osaka
TEL
06-6945-1181
ryu1486@gmail.com
Public contact
Name of contact person
| 1st name | Yugo |
| Middle name | |
| Last name | Iwaya |
Organization
Shinshu University, School of Medicine
Division name
Department of Medicine, Division of Gastroenterology and Hepatology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2634
Homepage URL
yiwaya@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
yiwaya@shinshu-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 | 12 | Month | 04 | 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
| 2024 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
High-quality NBI magnified images of neoplastic and non-neoplastic lesions arising in Barrett's esophagus will be collected prospectively from multiple institutions (STEP 1). Twenty image evaluators will be divided into two groups (conventional algorithm group and new algorithm group). Using the static images collected in STEP 1, each group will diagnose neoplastic and non-neoplastic lesions (STEP 2) to demonstrate the non-inferiority of the new algorithm compared to the conventional algorithm in terms of sensitivity.
Management information
Registered date
| 2024 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064377
