UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019319 |
|---|---|
| Receipt number | R000022226 |
| Scientific Title | prospective study of endoscopic evaluation for invasion depth of superficial esophageal cancers |
| Date of disclosure of the study information | 2015/10/13 |
| Last modified on | 2020/06/29 14:34:24 |
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Basic information
Public title
prospective study of endoscopic evaluation for invasion depth of superficial esophageal cancers
Acronym
endoscopic evaluation for invasion depth of superficial esophageal cancers
Scientific Title
prospective study of endoscopic evaluation for invasion depth of superficial esophageal cancers
Scientific Title:Acronym
endoscopic evaluation for invasion depth of superficial esophageal cancers
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the accuracy of the diagnosis of invasion depth in superficial esophageal SCC evaluated by Endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
accuracy rate of the diagnosis of invasion depth of the superficial esophageal SCC according to JES Classification
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patients who have a superficial esophageal SCC
2. Patients who underwent high definition endoscopic diagnosis for esophageal SCC
3. Patients who underwent image enhanced endoscopy for esophageal SCC
Key exclusion criteria
1.The patients treated by chemotherapy or radiotherapy for esophageal SCC
2. The patients treated by chemotherapy before resection of esophageal SCC
3.The patients who had been treated by chemotherapy or radiotherapy for esophageal SCC
4.The patients who have a severe underlying disease
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Okada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata, Okayama 700-8558, Japan
TEL
086-235-7218
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Hori |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata, Okayama 700-8558, Japan
TEL
086-235-7218
Homepage URL
hori-kei@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Gastroenterology and Hepatology
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address
2-5-1 Shikata, Okayama 700-8558, Japan
Tel
086-235-6503
mae6605@adm.okayama-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
| 2015 | Year | 10 | Month | 13 | 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
| 2015 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study for accuracy rate of the diagnosis of invasion depth of the superficial esophageal SCC according to JES Classification, in comparison with the accuracy of the invasion depth under non magnifying white light image.
Management information
Registered date
| 2015 | Year | 10 | Month | 12 | Day |
Last modified on
| 2020 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022226
| 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 |
