UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010926 |
|---|---|
| Receipt number | R000012785 |
| Scientific Title | Endoscopic findings detected using narrow-band imaging to distinguish between basal cell hyperplasia and squamous cell carcinoma of the pharynx |
| Date of disclosure of the study information | 2013/06/11 |
| Last modified on | 2013/06/11 09:56:40 |
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Basic information
Public title
Endoscopic findings detected using narrow-band imaging to distinguish between basal cell hyperplasia and squamous cell carcinoma of the pharynx
Acronym
NBI findings of BCH in the pharynx
Scientific Title
Endoscopic findings detected using narrow-band imaging to distinguish between basal cell hyperplasia and squamous cell carcinoma of the pharynx
Scientific Title:Acronym
NBI findings of BCH in the pharynx
Region
| Japan |
Condition
Condition
Basal cell hyperplasia of the pharynx and superficial-type head and neck squamous cell carcinoma
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study was to clarify the endoscopic characteristics of basal cell hyperplasia that contribute to the discrimination of superficial-type head and neck squamous cell carcinoma.
Basic objectives2
Others
Basic objectives -Others
The aim of the present study was to clarify the endoscopic characteristics of basal cell hyperplasia that contribute to the discrimination of superficial-type head and neck squamous cell carcinoma.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The size, intervascular transparency, variety of IPCL (intra-epithelial papillary capillary loop) shapes, and the distribution of the IPCLs
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were pathologically diagnosed as having BCH based on endoscopic biopsy samples of the pharynx obtained between January 2008 and July 2012 at our institute.
Key exclusion criteria
Cases without NBI-ME images or with only inappropriate images (blurry or unfocused) were excluded.
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kaneko |
Organization
National Cancer Center East
Division name
Department of Gastroenterology, Endoscopy Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cancer Center East
Division name
Department of Gastroenterology, Endoscopy Division
Zip code
Address
TEL
Homepage URL
ayagishi@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center East
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
| 2013 | Year | 06 | Month | 11 | 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
The size of the BCH lesions was significantly smaller (P < 0.001), and their intervascular transparency was more clearly observed (P < 0.001). IPCL (intra-epithelial papillary capillary loop) shapes were less variable and monotonous (P < 0.001), and the distribution of the IPCLs was more regular with an interval comparable to that of SCC (P < 0.001), though no significant differences in the sharpness of the lesion border or the morphological changes in the IPCLs were seen between the BCH and SCC 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
| 2013 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 10 | Day |
Other
Other related information
case control
retrospective
consecutive cases
Management information
Registered date
| 2013 | Year | 06 | Month | 11 | Day |
Last modified on
| 2013 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012785
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| Registered date | File name |
| Research case data | |
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