UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051145 |
|---|---|
| Receipt number | R000058310 |
| Scientific Title | A prospective observational study for the usefulness of Japan Esophageal Society Classification B2 for estimating cancer invasion depth in superficial esophageal squamous cell carcinomas |
| Date of disclosure of the study information | 2023/05/29 |
| Last modified on | 2025/05/24 20:49:11 |
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Basic information
Public title
A prospective observational study for the usefulness of Japan Esophageal Society Classification B2 for estimating cancer invasion depth in superficial esophageal squamous cell carcinomas
Acronym
Japan BEES study
Scientific Title
A prospective observational study for the usefulness of Japan Esophageal Society Classification B2 for estimating cancer invasion depth in superficial esophageal squamous cell carcinomas
Scientific Title:Acronym
Japan BEES study
Region
| Japan |
Condition
Condition
esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the usefulness of considering the size and macroscopic type of the B2 vascular area in addition to the depth diagnosis based on the classification by a magnifying endoscopy of the Japan Esophageal Society for the depth diagnosis of clinical MM/SM1 esophageal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy (the proportion of cases where the preoperative depth diagnosis matches the histological depth diagnosis)
Key secondary outcomes
1. Ratio of pSM2-3 when the size of the area where B2 vessels are observed is 10 mm or more
2. Ratio of pSM2-3 when the macroscopic type of the area where B2 vessels are observed is 0-I or 0-III
3. Ratio of pSM2-3 when the size of the area where B2 vessels are observed is 10 mm or more, or the macroscopic type is 0-I or 0-III
4. Ratio of pEP/LPM when the size of the area where B2 vessels are observed is 4 mm or less
5. Positive predictive value
6. Sensitivity
7. Specificity
8. Likelihood ratio
9. Correlation between the size of the B2 vascular area and the histological depth
10. Correlation between the number of B2 vascular areas and the histological depth
11. Relationship between the macroscopic type of the B2 vascular area and the histological depth
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. Patients diagnosed with histologically confirmed squamous cell carcinoma or clinically diagnosed esophageal squamous cell carcinoma.
2. Clinical T1 esophageal cancer where B2 vessels are observed but B3 vessels are not observed.
3. The part where B2 vessels are observed is diagnosed as the deepest part of the tumor.
4. The main occupation site of the tumor is the cervical, thoracic, or abdominal esophagus (UICC-TNM 8th edition).
5. The maximum diameter of the tumor is 50 mm or less.
6. Patients who wish to undergo endoscopic or surgical resection as initial treatment. However, only those without planned preoperative chemotherapy for overlapping head and neck or gastric cancer cases are eligible.
7. No simultaneous esophageal advanced cancer.
8. No history of surgical esophagectomy.
9. No history of radiation therapy to the esophagus, lung field, or mediastinum, including treatment for other cancer types.
10. Past endoscopic resection for esophageal cancer is not a concern. However, if the lesion is located within 10mm of the scar from previous treatment, the patient is ineligible.
11. The age at registration is 18 years or older.
12. Performance status (PS) is assessed according to the ECOG criteria and is between 0 and 2.
13. The patient has provided written consent for participation in the trial.
Key exclusion criteria
1. Patients with systemic infections requiring treatment.
2. Women who are pregnant, may be pregnant, or are breastfeeding.
3. Patients with psychiatric disorders, psychiatric symptoms, or cognitive impairments that make participation in the trial difficult.
4. Patients deemed inappropriate by the registering physician.
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Ishihara |
Organization
Osaka international Cancer Center
Division name
Gastrointestinal Oncology
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka, Japan
TEL
06-6945-1181
ryu1486@gmail.com
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Yoshida |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
ma.yoshida@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
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
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi, Shizuoka, Japan
Tel
055-989-5222 / +81-55-989-5222
tansaku_office@scchr.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
大阪国際がんセンター/Osaka International Cancer Center
鹿児島大学/Kagoshima University
がん研有明病院/Cancer Institute Hospital
恵佑会第2病院/Keiyukai Daini Hospital
国立がん研究センター中央病院/National Cancer Center Hospital
国立がん研究センター東病院/National Cancer Center Hospital East
静岡県立静岡がんセンター/Shizuoka Cancer Center
静岡県立総合病院/Shizuoka General Hospital
市立奈良病院/Nara City Hospital
仙台厚生病院/Sendai Kousei Hospital
長岡赤十字病院/Nagaoka Red Cross Hospital
広島大学/Hiroshima University
福岡大学筑紫病院/Fukuoka Umiversity Chikushi Hospital
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 29 | 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
136
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study. Data obtained within the scope of endoscopic examinations performed in daily clinical practice will be used to verify the usefulness of experimental preoperative depth diagnosis in addition to standard depth diagnosis methods. The clinical hypothesis of this study is "Improvement of the preoperative depth diagnosis accuracy by considering the size of the B2 vascular area and the macroscopic type of the B2 vascular area in addition to the conventional magnifying endoscopic classification based on the depth prediction of the standard preoperative depth diagnosis."
Management information
Registered date
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058310
