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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007585
Receipt No. R000008958
Scientific Title Randomized controlled trial on prototype magnifying endoscopy (ME) with narrow-band imaging (NBI) for diagnosis of superficial head and neck (H&N) and esophageal cancer
Date of disclosure of the study information 2012/04/01
Last modified on 2015/04/10

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Basic information
Public title Randomized controlled trial on prototype magnifying endoscopy (ME) with narrow-band imaging (NBI) for diagnosis of superficial head and neck (H&N) and esophageal cancer
Acronym H&N and Esophagus prototype MENBI trial
Scientific Title Randomized controlled trial on prototype magnifying endoscopy (ME) with narrow-band imaging (NBI) for diagnosis of superficial head and neck (H&N) and esophageal cancer
Scientific Title:Acronym H&N and Esophagus prototype MENBI trial
Region
Japan

Condition
Condition H&N and Esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparison of diagnostic performance for superficial H&N and esophageal cancer between prototype ME and current ME in conjunction with NBI
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of detection rate of superficial H&N and esophageal cancer between prototype ME and current ME in conjunction with NBI
Key secondary outcomes Comparison of accuracy of superficial H&N and esophageal cancer between prototype ME and current ME in conjunction with NBI

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Prototype ME
Interventions/Control_2 Current ME
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 Female
Key inclusion criteria H&N cancer
esophageal cancer
squamous cell carcinoma
no prior radiotherapy and chemotherapy
Key exclusion criteria esophageal stenosis
esophageal varices
Target sample size 74

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Goda
Organization The Jikei University School of Medicine
Division name Department of Endoscopy
Zip code
Address 3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Goda
Organization The Jikei University School of Medicine
Division name Department of Endoscopy
Zip code
Address 3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL 03-3433-1111
Homepage URL
Email

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Jikei University School of Medicine
Organization
Division
Category of Funding Organization Other
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 東京慈恵会医科大学付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Ninety-three patients participated; a total of 28 SCs were detected in the pharynx and esophagus. The detection rates of DF-NBI and CM-NBI for SC were 82% and 71%, respectively. The lower limit of the 90% confidence interval for differences between the detection rates exceeded the noninferiority threshold. Although not significantly different, the other diagnostic values tended to be higher for DF-NBI than CM-NBI. The results of questionnaires answered by endoscopists showed DF-NBI received a significantly higher or nearly significantly higher evaluation than CM-NBI, excepting a single question.
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
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 12 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
2012 Year 03 Month 27 Day
Last modified on
2015 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008958

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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