UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049921 |
|---|---|
| Receipt number | R000056807 |
| Scientific Title | Utility of magnifying endoscopy for diagnosing superficial esophageal cancer: A single-center prospective observational study |
| Date of disclosure of the study information | 2022/12/27 |
| Last modified on | 2022/12/27 19:00:16 |
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Basic information
Public title
Utility of magnifying endoscopy for diagnosing superficial esophageal cancer: A single-center prospective observational study
Acronym
Utility of magnifying endoscopy for diagnosing superficial esophageal cancer: A single-center prospective observational study
Scientific Title
Utility of magnifying endoscopy for diagnosing superficial esophageal cancer: A single-center prospective observational study
Scientific Title:Acronym
Utility of magnifying endoscopy for diagnosing superficial esophageal cancer: A single-center prospective observational study
Region
| Japan |
Condition
Condition
Superficial esophageal cancer, Squamous intraepithelial neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The diagnosis of superficial esophageal cancer based on vascular architecture is subjective. To evaluate the diagnostic utility of the regularity of microvascular alignment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The positive predictive value of regular and irregular microvascular alignment for the diagnosis of superficial esophageal cancer and squamous intraepithelial neoplasia.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients in whom upper endoscopy revealed an esophageal lesion with a 7-mm or larger border.
2.Lesion with enlarged, well-aligned, dilated vessels on NBI magnification.
Key exclusion criteria
1.Patients who cannot undergo a biopsy, such as receiving multiple anti-thrombotic medications
2.Patients with a previous, histological diagnosis of esophageal cancer
3.Patients in whom a histological diagnosis cannot be made on the basis of a biopsy
Target sample size
198
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Iizuka |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Division name
Department of Gastroenterology
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-Ku, Tokyo
TEL
03-3823-2101
minami373323@gmail.com
Public contact
Name of contact person
| 1st name | Ryogo |
| Middle name | |
| Last name | Minami |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Division name
Department of Gastroenterology
Zip code
113-8677
Address
Department of Gastroenterology
TEL
03-3823-2101
Homepage URL
minami373323@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Address
3-18-22 Honkomagome, Bunkyo-Ku, Tokyo
Tel
03-3823-2101
minami373323@gmail.com
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
| 2022 | Year | 12 | Month | 27 | 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
| 2022 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2022 | Year | 12 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056807
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
