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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003766
Receipt No. R000004561
Scientific Title Magnifyin endoscopy with narrow band imaging versus endoscopic ultrasonography for predicting the invasion depth of superficial esophageal squamous cell carcinoma
Date of disclosure of the study information 2010/06/16
Last modified on 2010/12/20

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Basic information
Public title Magnifyin endoscopy with narrow band imaging versus endoscopic ultrasonography for predicting the invasion depth of superficial esophageal squamous cell carcinoma
Acronym NBI vs EUS for predicting the invasion depth of esophageal carcinoma
Scientific Title Magnifyin endoscopy with narrow band imaging versus endoscopic ultrasonography for predicting the invasion depth of superficial esophageal squamous cell carcinoma
Scientific Title:Acronym NBI vs EUS for predicting the invasion depth of esophageal 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 compare the diagnostic accuracy of the invaion depth of superficial squamous cell carcinoma of the esophagus between EUS and NBI with magnifying endoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnosis of invaion depth of superficial squamous cell carcinoma of the esophagus by EUS and NBI with magnifying endoscopy
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 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 To evaluate the invasion depth of superficial squamous cell carcinoma by EUS and NBI with magnifying endoscopy from Jun 2010 through Jun 2012.
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. Histologically confirmed squamous cell carcinoma.
2. Patients with superficial esophageal carcinoma
3. Patients without major organ failure.
4. A written informed concent is obtained.
5. Patients scheduled to underwent endoscopic resection or surgery.
Key exclusion criteria 1. Hemorrhagic diseases
2. Patients with other advanced cancer
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ishihara Ryu
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastrointestinal Oncology
Zip code
Address 1-3-3 Nakamichi, Higashinariku, Osaka 537-8511 Japan
TEL 06-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hanaoka Noboru
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastrointestinal Oncology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization none
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
Email

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
2010 Year 06 Month 16 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
2010 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 06 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
2010 Year 06 Month 16 Day
Last modified on
2010 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004561

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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