UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045891 |
|---|---|
| Receipt number | R000052391 |
| Scientific Title | The study of endocytoscopic observation for esophageal squamous lesions |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2022/05/16 11:19:42 |
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Basic information
Public title
The study of endocytoscopic observation for esophageal squamous lesions
Acronym
endocytoscopic observation for esophageal squamous lesions
Scientific Title
The study of endocytoscopic observation for esophageal squamous lesions
Scientific Title:Acronym
endocytoscopic observation for esophageal squamous lesions
Region
| Japan |
Condition
Condition
esophageal squamous lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the acquisition rate of appropriate endocytoscopic figures for the brownish area found by narrow band imaging in esophagus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the acquisition rate of appropriate endocytoscopic figures
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
endocytoscopy with narrow band imaging
Interventions/Control_2
endocytoscopy without narrow band imaging
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
i) age over 20
ii) brownish area within 20mm in esophagus found by narrow band imaging
iii) written informed consent
Key exclusion criteria
1)Patients with prior chemotherapy or radiotherapy to the esophagus
ii)refusal of written informed consent
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Keitaro |
| Middle name | |
| Last name | Takahashi |
Organization
Asahikawa medical university
Division name
Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
TEL
0166-68-2462
ktakaha@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Takahashi |
Organization
Asahikawa medical university
Division name
Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
TEL
0166-68-2462
Homepage URL
ktakaha@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa medical university
Institute
Department
Personal name
Funding Source
Organization
Asahikawa medical 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
Asahikawa medical university
Address
2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, Japan
Tel
0166-68-2462
ktakaha@asahikawa-med.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
| 2021 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052391
