UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004404 |
|---|---|
| Receipt number | R000005266 |
| Scientific Title | Clinical study on Narrow Band Imaging (NBI) for diagnosis of superficial esophageal cancer |
| Date of disclosure of the study information | 2010/10/18 |
| Last modified on | 2011/06/15 10:52:27 |
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Basic information
Public title
Clinical study on Narrow Band Imaging (NBI) for diagnosis of superficial esophageal cancer
Acronym
NBI study for Esophageal cancer
Scientific Title
Clinical study on Narrow Band Imaging (NBI) for diagnosis of superficial esophageal cancer
Scientific Title:Acronym
NBI study for Esophageal cancer
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 esophageal cancer in high-risk patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We aimed to compare the diagnostic performance of NBI and iodine staining during a single tandem procedure.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
NBI and Iodine staining
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Head and neck cancer
Post EMR for early esophageal cancer
Key exclusion criteria
1.Known esophageal cancer
2.esophageal stenosis
3.patient performed iodine staining within 6 week
4.patient undergone chemotherapy or radiotherapy
5.Iodin allergy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Arakawa |
Organization
Department of Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
1-5-7 Asahimachi abenoku osakacity
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
TEL
0666452316
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology Osaka City University Graduate School of Medicine
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
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 | 10 | Month | 18 | 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
Completed
Date of protocol fixation
| 2008 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 18 | Day |
Last modified on
| 2011 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005266
