UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013516 |
|---|---|
| Receipt number | R000014937 |
| Scientific Title | A validation study for simplified criteria of NBI magnifying endoscopy for superficial esophageal squamous cell carcinoma (SCC) |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/11/09 21:19:48 |
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Basic information
Public title
A validation study for simplified criteria of NBI magnifying endoscopy for superficial esophageal squamous cell carcinoma (SCC)
Acronym
Simplefied criteria study
Scientific Title
A validation study for simplified criteria of NBI magnifying endoscopy for superficial esophageal squamous cell carcinoma (SCC)
Scientific Title:Acronym
Simplefied criteria study
Region
| Japan |
Condition
Condition
superficial esophageal SCC
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validation study for the newly simplified criteria of NBI magnifying endoscopy for superficial esophageal squamous cell neoplasms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivities of white light endoscopy and NBI magnifying endoscopy based on newly simplified criteria for superficial esophageal SCC
Key secondary outcomes
#Diagnostic yields of superficial esophageal SCC based on newly simplified criteria
#Comparison of diagnostic yields for superficial esophageal SCC based on between newly simplified criteria and conventional criteria
#Diagnostic yields of superficial esophageal SCC based on newly simplified criteria depending on status of lugol staining
#Evaluation of histopathological characteristics of superficial esophageal SCCs which were overlooked by NBI magnifying endoscopy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
NBI magnifying endoscopy
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
The patients with present or past history of SCC in the head and neck or esophagus.
The patients who agree with the informed consent
Key exclusion criteria
1.The patients who have preexisting serious disease
2.The patients who have history of radiotherapy for esophageal cancer
3.The patients who have already take chemotherapy
4.The patients who take antithrombotic drug
5.The patients who are evaluated inappropriate for the research
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Dobashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
ad99061@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Dobashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
ad99061@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research fund of The Jikei University School of Medicine, Department of Endoscopy
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
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
東京慈恵会医科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 26 | Day |
Last modified on
| 2015 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014937
