UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007709 |
|---|---|
| Receipt number | R000009063 |
| Scientific Title | Study of the usefulness of surface pattern observed by magnifying narrow-band imaging(NBI) in early colorectal cacner:Pilot study |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2014/08/24 20:07:38 |
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Basic information
Public title
Study of the usefulness of surface pattern observed by magnifying narrow-band imaging(NBI) in early colorectal cacner:Pilot study
Acronym
Surface pattern of early colorectal cancer
Scientific Title
Study of the usefulness of surface pattern observed by magnifying narrow-band imaging(NBI) in early colorectal cacner:Pilot study
Scientific Title:Acronym
Surface pattern of early colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate if surface pattern by magnifying NBI can be used to predict invasion depth in colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1)Diagnostic specifity
(2)Diagnostic sensitivity
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Magnified endoscopy with NBI
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
(1)Early coloretal cancer(intramucosal cancer or submucosal invasive cancer)
(2)Lesions observed by magnifying NBI
(3)Over 20 years old
(4)Written informed consent
Key exclusion criteria
(1)Advanced colorectal cancer(T2 or more)
(2)Low or high grade adenoma
(3)Poor condition to obtain appropriate endoscopic images
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Misawa |
Organization
Showa University, Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL
045-949-7265
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Misawa |
Organization
Showa University, Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL
Homepage URL
misawaanny@ybb.ne.jp
Sponsor or person
Institute
Showa University, Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23673484
Number of participants that the trial has enrolled
Results
Narrow-band imaging (NBI) of surface microvessels of colorectal lesions is useful for differentiating neoplasms from non-neoplasms and for predicting histopathological diagnosis. Furthermore, NBI of surface microstructure, or 'surface pattern', is valuable for predicting histopathology in colorectal cancer. The aim of the present study was to investigate whether surface patterns could be used to predict invasion depth in colorectal cancer, and to compare the accuracy of surface pattern diagnosis in each macroscopic type. Between January 2010 and March 2011, a series of 357 consecutive patients with 378 early colorectal cancers were observed by magnifying NBI and the surface pattern was prospectively evaluated. Surface pattern was classified into 3 types: type I, microstructure was clearly recognised with uniform arrangement and form; type II, microstructure was obscured with heterogeneous arrangement and form; and type III, microstructure was invisible. We also classified the macroscopic type into 3 categories: depressed, protruded and flat elevated. Assuming that type III was an index of massively invasive lesions in the submucosal layer (SMm), the sensitivity, specificity and accuracy were 56.9, 91.7 and 85.7%, respectively. The sensitivity, specificity and accuracy of type III for the diagnosis of SMm in each macroscopic type were: depressed, 88.9, 40.0 and 63.2%, respectively; protruded: 34.8, 96.4 and 90.0%, respectively; and flat elevated, 54.2, 92.7 and 85.0%, respectively. These results suggest that the diagnostic accuracy of surface pattern was insufficient and particularly poor for depressed-type lesions.
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
| 2009 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
This study was registered on UMIN-CTR after finished.
Management information
Registered date
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2014 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009063
