UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011614 |
|---|---|
| Receipt number | R000013585 |
| Scientific Title | Prospective multicenter study of the usefulness of Japan Esophageal Society (JES) Classification of magnified endoscopy for the diagnosis of superficial esophageal squamous cell carcinoma (SCC) |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2023/10/22 22:42:46 |
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Basic information
Public title
Prospective multicenter study of the usefulness of Japan Esophageal Society (JES) Classification of magnified endoscopy for the diagnosis of superficial esophageal squamous cell carcinoma (SCC)
Acronym
JES Classification study
Scientific Title
Prospective multicenter study of the usefulness of Japan Esophageal Society (JES) Classification of magnified endoscopy for the diagnosis of superficial esophageal squamous cell carcinoma (SCC)
Scientific Title:Acronym
JES Classification study
Region
| Japan |
Condition
Condition
superficial esophageal SCC
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 JES Classification
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 targeted area in superficial esophageal SCC according to JES Classification
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Magnified endoscopy with NBI
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)The patients who have a superficia esophageal SCC treated by endoscopic resection or esophagectomy
(2)The patients who agreed with informed consent
Key exclusion criteria
(1)The patients who have an iodine hypersensitivity
(2)The patients who had been treated by chemotherapy or radiotherapy for esophageal SCC
(3)The patients who have a severe underlying disease
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuneo Oyama |
Organization
Saku Central Hospital
Division name
Department of Gastroenterology Endoscopy division
Zip code
Address
197 Usuda, Saku-city, Nagano 384-0301, Japan
TEL
0267-82-3131
oyama@coral.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Takeuchi |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8520, Japan
TEL
025-227-2207
Homepage URL
yasuzuka2000@yahoo.co.jp
Sponsor or person
Institute
Japan Esophageal Society (JES)
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
Tokyo Komagome Hospital
Sitama Cancer Center
Keio University
Osaka Medical Center
Jikei University
Sendai Open Hospital
Nagasaki Unversity
Kawasaki Municipal Hospital
Tokyo Medical and Dental University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013585
