UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007585 |
|---|---|
| Receipt number | 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 11:45:22 |
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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
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
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008958
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
