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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000242
Receipt No. R000000305
Scientific Title Randomized clinical study on Narrow Band Imaging (NBI) for diagnosis of superficial head and nack and esophageal cancer
Date of disclosure of the study information 2005/09/20
Last modified on 2006/03/30

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Basic information
Public title Randomized clinical study on Narrow Band Imaging (NBI) for diagnosis of superficial head and nack and esophageal cancer
Acronym H&N and Esophagus NBI-STUDY
Scientific Title Randomized clinical study on Narrow Band Imaging (NBI) for diagnosis of superficial head and nack and esophageal cancer
Scientific Title:Acronym H&N and Esophagus NBI-STUDY
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate of the usefulness of NBI systenm for diagnosis of superficial head and neck and esophageal cancer in the esophageal caner patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of the detection rate of superficial head and neck cancer between NBI and conventional obseravation in the esophageal caner patients
Key secondary outcomes Comparison of the diagnostic accuracy of superficial head and neck cancer between NBI and conventional obseravation in the esophageal caner patients

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 NBI
Interventions/Control_2 control
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 esophageal cancer
squamous cell carcinoma
no prior radiotherapy and chemotherapy
Key exclusion criteria esophageal stenosis
esophageal varices
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization National Cancer Center Hospital East
Division name Division of Digestive Endoscopy and GI Oncology
Zip code
Address 6-5-1 Kashiwanoha Kashiwa, Chiba, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Muto
Organization Natioanal Cancer Center Hospital East
Division name Division of Digestive Endoscopy and GI Oncology
Zip code
Address
TEL 04-7133-1111
Homepage URL
Email

Sponsor
Institute Innovation of New Diagnositic Modarities and Research on their diagnostic accuracy
Institute
Department

Funding Source
Organization Ministry of Health and Welfare
Organization
Division
Category of Funding Organization
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
2005 Year 09 Month 20 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 No longer recruiting
Date of protocol fixation
2004 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2005 Year 03 Month 01 Day
Last follow-up date
2007 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 20 Day
Last modified on
2006 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000305

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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