UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005632 |
|---|---|
| Receipt number | R000006655 |
| Scientific Title | Validation study of magnifying endoscopy with narrow band imaging to predict depth of invasion for superficial esophageal squamous cell carcinoma, in addition to standard endoscopy |
| Date of disclosure of the study information | 2011/05/24 |
| Last modified on | 2014/03/07 00:11:10 |
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Basic information
Public title
Validation study of magnifying endoscopy with narrow band imaging to predict depth of invasion for superficial esophageal squamous cell carcinoma, in addition to standard endoscopy
Acronym
Validation study of magnifying endoscopy with narrow band imaging to predict depth of invasion for superficial esophageal squamous cell carcinoma
Scientific Title
Validation study of magnifying endoscopy with narrow band imaging to predict depth of invasion for superficial esophageal squamous cell carcinoma, in addition to standard endoscopy
Scientific Title:Acronym
Validation study of magnifying endoscopy with narrow band imaging to predict depth of invasion for superficial esophageal squamous cell carcinoma
Region
| Japan |
Condition
Condition
Patients with superficial squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To access accuracy of the invasion depth for superficial esophageal squamous cell carcinoma by magnifying endoscopy with narrow band imaging (ME-NBI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy rate for invasion depth of superficial esophageal squamous cell carcinoma between standard endoscopy (SE) and ME-NBI
Key secondary outcomes
Sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate between SE and ME-NBI, for esophageal cancer beyond muscularis mucosae invasion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
SE followed by ME-NBI for diagnosis of invasion depth for superficial esophageal squamous cell carcinoma
From May 2011 to March 2014
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically confirmed high grade intraepithelial neoplasia or squamous cell carcinoma
2.Superficial esophageal cancer with flat type
3.20 years old =< age =< 85 years old
4.PS:0-2
5.Written informed consent
Key exclusion criteria
1.Patients with strong anticoaglant therapy
2.Severe heart, lung and renal dysfunction
3.Weak patients who can not be resected by endoscopy or surgery
4.Patients who will be treated by radiation therapy, chemotherapy and APC
5.Cervical esophageal cancer
6.Investigator's decision
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shimura Takaya |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
TEL
052-853-8211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ebi Masahide |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
TEL
052-853-8211
Homepage URL
ebissen@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya Daini Red Cross Hospital
Chukyo Hospital
Nagoya City East Medical Center
Nagoya City West Medical Center
Gifu Prefectural Tajimi Hospital
Nagoya Memorial Hospital
Kasugai Municipal Hospital
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
名古屋市立大学病院（愛知県）、名古屋第二赤十字病院（愛知県）、社会保険中京病院（愛知県）、名古屋市立東部医療センター（愛知県）、名古屋市立西部医療センター（愛知県）、岐阜県立多治見病院（岐阜県）、名古屋記念病院（愛知県）、春日井市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 24 | 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
| 2011 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 23 | Day |
Last modified on
| 2014 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006655
