UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000242 |
|---|---|
| Receipt number | 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 19:10:07 |
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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
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
Sponsor or person
Institute
Innovation of New Diagnositic Modarities and Research on their diagnostic accuracy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000305
